LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes softw

FDA device recall Z-1993-2016 · posted 2016-06-15 · Terminated

Recall details

Recalling firm

Physio-Control, Inc.

Reason for recall

The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 value. This affects all LIFEPAK 15 with an EtC02 feature installed and configured to the kPa or % setting.

Action taken

Physio-Control sent the letter with the title Information Regarding LIFEPAK 15 MONITOR/DEFIBRILLATOR WITH End-tidal CO2 OPTION, dated January 2016, to customers in the United Kingdom (UK) as REQUESTED by the Medicines and Healthcare product Regulatory Agency (MHRA) on January 27, 2016. Physio initiated a voluntary field action on February 23, 2016 and started notifying US consignees on March 22, 2016 and started notifying international consignees on April 18, 2016. The Information Regarding LIFEPAK 15 MONITOR/ DEFIBRILLATOR WITH End-tidal CO2 OPTION letter, dated March 2016, was sent. Customer Letters began mailing in EMEA region, beginning on 06/20/2016 via designated Courier. Customer Letters began mailing in Canada on 09/09/2016 via FedEx. Customer Letters began mailing in Latin America on 09/16/2016 via email. Customer Letters began mailing in APAC region on 09/22/2016 via email. Second Customer letters with Confirmation Sheets began mailing in the US October 2016 via FedEx and USPS Certified Mail. Actions should be taken by users: 1. Please forward this information to all of your sites, trainers and users that may have a LIFEPAK 15 monitor/defibrillator. 2. If you use your LIFEPAK 15 monitor/defibrillator to display EtC02 values you should also display the EtC02 waveform which includes the range along the right side of the display. 3. If you use either kPa or % settings, activate EtC02 alarms to identify EtC02 values outside the normal range. 4. If your protocols allow this option, consider changing the EtC02 to measure in the mmHg setting. The firm reported that the revised software for LifePak15 version 4 (v4) and the customer install instructions would be available on LIFENET by April 25, 2016. The revised software for LifePak 15 versions 1 and 2 (v1 and v2) and the customer install instructions are estimated to be available on LIFENET in mid May 2016. Customers who have any questions about this subject, please contac

Root cause

Software design

Status

Terminated

Product code

MKJ

Quantity affected

44798 units total (23189 units in US; 21609 units international)

Distribution

Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bos

Date initiated

2016-01-27

Date posted

2016-06-15

Date terminated

2017-03-31

Location

Redmond, WA

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