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

Model Number	20
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.Physio found broken pieces of the device's therapy pcb assembly inside the bottom case, damage to the j2 capacitor connector, and damage to the front and top cases.The therapy pcb assembly, capacitor connector, front and top cases were replaced to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation by physio-control it was found that the device logged a critical event code.The event code is indicative of a device issue that could result in a partial loss of defibrillator output energy due to a loss of the negative or positive portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation by physio-control it was found that the device logged a critical event code.The event code is indicative of a device issue that could result in a partial loss of defibrillator output energy due to a loss of the negative or positive portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.
Additional Manufacturer Narrative
Although the customer initially reported their device was functional, physio-control found that the customer's device was unable to deliver energy in the reported condition.Physio-control further evaluated the removed therapy pcb assembly found diodes cr43 and cr44 were shorted.Physio determined that the cause of the reported issue was likely shorted diode cr44.

• 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: 10715051
• Report Number: 0003015876-2020-01560
• Device Sequence Number: 19816644
• Product Code: MKJ
• UDI-Device Identifier: 00883873813737
• UDI-Public: 00883873813737
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 11/10/2020

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: 99402-000001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1