Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941

FDA device recall Z-2151-2025 · posted 2025-07-21 · Open, Classified

Recall details

Recalling firm

Covidien

Reason for recall

Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

Action taken

On 6/23/2025 correction notices were distributed to customers who where informed: Per Operator s Manual (http://manuals.medtronic.com): 1) Device alarm volume needs to be set to a level appropriate to be heard throughout the care environment at all times of day or night. Do not silence or decrease the volume of the audible alarm if patient safety could be compromised. 2) If the sensor comes off the patient, or no perfusion is detected, the device will notify 'sensor off' (low priority alarm) every 16 seconds and display a steady yellow visual indicator. If a low priority alarm immediately follows a higher priority alarm, a user may not recognize the higher priority clinical condition. 3) Monitors should be set to Standard Mode when in use in a hospital or hospital-type environment by trained medical personnel and set to Homecare Mode when a lay person will be using the monitor outside of a hospital or other professional care setting. With the monitor not in Homecare Mode, alarms could be silenced/muted and alarm limits altered In Clinical Facility Environments be sure the PM100N model is set to Standard Mode for general use and only set to Sleep Study Mode when conducting a sleep study. Device should be set to Homecare Mode prior to use. Firm's Technical Service at 800-255-6774 (option 1, then 2) can provide a four-digit password required to set a monitor to Homecare Mode. Provide the Home Use Guide to home caregivers. Clinicians should communicate the recall information to home use patients and caregivers. Pass on/post this notice for all those who need to be aware within your organization and to any organization where the product has been transferred/distributed. Complete and return the Customer Confirmation Form to rs.gmbmitgfca@medtronic.com Firm will provide additional information when finalized. Questions - Contact firm's Customer Service at 800-962-9888, Option 2.

Root cause

Labeling design

Status

Open, Classified

Product code

DQA

Quantity affected

264,790

Distribution

Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS, IN, IL, TN, MO, IA, OK, WI, AK, NY, MD, AL, WV, GA, NC, AR, WA, SD, KY, DE, NJ, UT

Date initiated

2025-06-23

Date posted

2025-07-21

Location

Boulder, CO

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