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

Model Number	20
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device reached its end of life on 12/23/2020 and physio was unable to evaluate the device.The customer's therapy cable which was in use at the time of the event was evaluated.One on the pins was visibly broken off and the date code on the cable was 5/2003.The recommended replacement for this cable per the service manual is every 3 years.This cable was connected to another lp20 and the customer's complaint was duplicated.The customer was informed of recommended replacement on the cable.
Event or Problem Description
The customer contacted physio-control to report that their device failed to detect attachment to the patient.This issue is patient related; however there was no adverse event reported.
Event or Problem Description
The customer contacted physio-control to report that their device failed to detect attachment to the patient.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Root cause is unable to be determined.

• Brand Name: LIFEPAK 20 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11363768
• Report Number: 0003015876-2021-00445
• Device Sequence Number: 4760302
• Product Code: MKJ
• UDI-Device Identifier: 00883873813812
• UDI-Public: 00883873813812
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1