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

Model Number	15
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device failed to shock.In this state the device may not be able to deliver defibrillation therapy if needed.Customer proceeded with another device.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
Stryker performed an initial evaluation of the customer's device and was unable to verify or duplicate the reported issue.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.Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.
Event or Problem Description
The customer contacted stryker to report that their device failed to shock.In this state the device may not be able to deliver defibrillation therapy if needed.Customer proceeded with another device.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
Stryker evaluated the software logs and verified the issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.
Additional Manufacturer Narrative
Section h10/h11 additional mfg narrative of supplemental medwatch report 001 indicates: stryker evaluated the software logs and verified the issue.Section h10/h11 additional mfg narrative of supplemental medwatch report 001 should indicate: the patient record files were reviewed and no device malfunction was found on the date of the incident.No parts were replaced.Results code has been updated from operational problem identified to no device problem found.
Event or Problem Description
The customer contacted stryker to report that their device failed to shock.In this state the device may not be able to deliver defibrillation therapy if needed.Customer proceeded with another device.This issue is patient related; however there was no adverse event reported.

• 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: 13760030
• Report Number: 0003015876-2022-00356
• Device Sequence Number: 14936585
• Product Code: MKJ
• UDI-Device Identifier: 00883873911778
• UDI-Public: 00883873911778
• 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,Followup
• Report Date (Section B): 05/18/2022

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: 99577-001242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022; 05/13/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/19/2022; 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2014
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Hispanic
• Patient Race: White