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

Model Number	15
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker performed an initial evaluation of 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.
Event or Problem Description
The customer contacted stryker to report that the shock button on their device was intermittent.The customer advised the button had to be pressed several times to deliver therapy.In this state defibrillation therapy would be delayed or unavailable if needed.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report that the shock button on their device was intermittent.The customer advised the button had to be pressed several times to deliver therapy.In this state defibrillation therapy would be delayed or unavailable if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Corrected information: section d9 of the initial medwatch report (mfr report #0003015876-2022-02715) indicates: product available to stryker - field section d9 of the initial medwatch report (mfr report #0003015876-2022-02715) should indicate: product available to stryker - no section d9 of the initial medwatch report (mfr report #0003015876-2022-02715) indicates: returned to manufacturer on - 12/14/2022 section d9 of the initial medwatch report (mfr report #0003015876-2022-02715) should indicate: returned to manufacturer on - blank section h3 of the initial medwatch report (mfr report #0003015876-2022-02715) indicates: device evaluated by mfg - yes section h3 of the initial medwatch report (mfr report #0003015876-2022-02715) should indicate: device evaluated by mfg - no reason for no evaluation - other reason code - other - not returned to manufacturer section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2022-02715) indicates: additional mfg narrative type ¿ stryker performed an initial evaluation of 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.Section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2022-02715) should indicate: additional mfg narrative type ¿ stryker verified the reported issue over the phone with the customer.Stryker determined that the cause of the reported issue was due to the main keypad.The replacement keypad was sent to the customer to resolve the issue.H3 other text : not returned to manufacturer.

• 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: 15996815
• Report Number: 0003015876-2022-02715
• Device Sequence Number: 6089272
• Product Code: MKJ
• UDI-Device Identifier: 00883873871607
• UDI-Public: 00883873871607
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 99577-001966
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 03/04/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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