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

Model Number	15
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.Upon evaluation of the customer¿s device, stryker observed that the device intermittently displayed "connect electrodes".When the device was able to charge successfully for defibrillation, intermittently it was disarm itself and the shock was not delivered.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.In addition it was observed that one shock was below the normal tolerance.As a result, the wrong defibrillation therapy would be delivered, if it were necessary.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker performed an initial evaluation of the customer¿s device and verified the reported issue.Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Additional Manufacturer Narrative
Stryker further evaluated the customer's device and was unable to duplicate the reported issue.During visual inspection it was observed that the device therapy connector had a pinch mark on one of the therapy connector's high voltage wires.The therapy connector assembly was replaced as a precaution.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing,.The device was returned to the customer for use.Stryker further evaluated the removed therapy connector assembly and confirmed the pinched wire, however the connector was functional.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.Upon evaluation of the customer¿s device, stryker observed that the device intermittently displayed "connect electrodes".When the device was able to charge successfully for defibrillation, intermittently it was disarm itself and the shock was not delivered.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.In addition it was observed that one shock was below the normal tolerance.As a result, the wrong defibrillation therapy would be delivered, if it were necessary.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 14525174
• Report Number: 0003015876-2022-00807
• Device Sequence Number: 6008837
• Product Code: MKJ
• UDI-Device Identifier: 00883873911457
• UDI-Public: 00883873911457
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/31/2022

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: 99577-001268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2011
• 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