MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE

Model Number	15
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
The customer contacted physio-control to report that their device will not charge for defibrillation - gives 'connect electrodes' or 'electrodes not detected".In this state the device would not be able to deliver defibrillation therapy if needed.There was no patient involvement reported associated to this event.
Event or Problem Description
The customer contacted physio-control to report that their device will not charge for defibrillation - gives 'connect electrodes' or 'electrodes not detected".In this state the device would not be able to deliver defibrillation therapy if needed.There was no patient involvement reported associated to this event.
Additional Manufacturer Narrative
Stryker received a report that the reported issue was resolved by the customer and released back to service.So the customer did not provide the device for service and device was not evaluated.The reported issue could not be verified and root cause is unable to be determined.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 12371622
• Report Number: 0003015876-2021-01665
• Device Sequence Number: 3902112
• Product Code: MKJ
• UDI-Device Identifier: 00883873979358
• UDI-Public: 00883873979358
• 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): 12/06/2021

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: 15
• Device Catalogue Number: 99577-000061
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown