MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control performed an initial evaluation of the customer's device and was able to duplicate the reported issue.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that when attempting to power on their device, it will not complete the boot-up process.As a result, defibrillation may not be possible, if it were necessary.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control further evaluated the customer's device and observed that the w18 user interface flex cable had lifted contacts on multiple pins that was causing the device to reset.Physio replaced the w18 user interface flex cable, which resolved the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the removed w18 user interface flex cable and observed the strain relief of the cable mounted plug connector, designator p21, was observed to be broken and c-2 (+usb) was open which resulted in the device to reboot when the cable was flexed.

Event Description

The customer contacted physio-control to report that when attempting to power on their device, it will not complete the boot-up process.As a result, defibrillation may not be possible, if it were necessary.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK® 20 DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 7656230
• MDR Text Key: 112995977
• Report Number: 0003015876-2018-01032
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1