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

Model Number	15
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device was not charging up when attempting to deliver defibrillation therapy.Upon evaluation by stryker, it was also found that the device was delivering abnormal energy.In this state wrong defibrillation therapy may be delivered.There was no report of patient use associated to the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customers device and was able to verify and duplicate the reported issue.The device could not be repaired in the field and will be returned to stryker for further evaluation.Stryker 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.
Additional Manufacturer Narrative
The initial medwatch report # 0003015876-2022-01961 was submitted in error and is a duplicate of medwatch report # 0003015876-2022-01910.
Event or Problem Description
The customer contacted stryker to report that their device was not charging up when attempting to deliver defibrillation therapy.Upon evaluation by stryker, it was also found that the device was delivering abnormal energy.In this state wrong defibrillation therapy may be delivered.There was no report of patient use associated to the reported event.

• 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: 15311744
• Report Number: 0003015876-2022-01961
• Device Sequence Number: 6192567
• 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): 12/27/2022

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: 99577-000061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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