Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal batter

FDA device recall Z-0343-2007 · posted 2007-01-19 · Terminated

Recall details

Recalling firm

MRL, Inc., A Welch Allyn Company

Reason for recall

Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient.

Action taken

MRL sent Urgent Medical Device Recall letters dated 11/8/06 via certified mail on 11/15/06 to the direct accounts informing them of an intermittent connection between the J5 cable and its mating connector on a circuit board inside of the device that could result in a malfunction that could prevent or unacceptably delay the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units'' parts/serial numbers and were requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. Until their PIC 50 is serviced, the accounts were instructed to check the unit before each shift by using the self-test, which is automatically initiated by powering up the device. If the 'ECG Comm' error occurs during use, cycling the power off-on may clear the error. Even if power cycling clears the device, the accounts were instructed to contact Welch Allyn - MRL to obtain priority servicing of the affected unit. The accounts were also instructed to respond to the notification within 30 days by fax or mail, or by calling Welch Allyn - MRL Technical Support at 1-800-462-0777, to schedule their PIC 50 for preventative service. Welch Allyn will provide the accounts with a loaner PIC 50 after receiving the form with instructions to send back the PIC 50 in the same shipping box accompanying the loaner unit. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.

Root cause

Other

Status

Terminated

Product code

MJK

Quantity affected

510 units

Distribution

Worldwide-USA, Australia, Belgium, Canada, Egypt, Finland, France, Germany, Ireland, Italy, Jordan, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sultanate of Oman, United Arab Emira

Date initiated

2006-11-15

Date posted

2007-01-19

Date terminated

2007-10-31

Location

Buffalo Grove, IL

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