MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that the 3 lead-electrodes of their lifepak 20 device had burned the skin of the patient.It was reported that the patient did sustain skin burns.The patient associated with the reported event did not survive, however the health care provider involved stated that they do not believe the device use contributed to the patient outcome.
Additional Manufacturer Narrative
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.A clinical review was performed and determined that there is insufficient data available to determine the impact of the device use, and therefore it is concluded the device contribution to the reported event is unknown.Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) (b)(4) of the (b)(6) parliament and of the council.
Additional Manufacturer Narrative
Stryker has made multiple attempts to contact the customer regarding the status of their device, but no response has been received from the customer.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that the 3 lead-electrodes of their lifepak 20 device had burned the skin of the patient.It was reported that the patient did sustain skin burns.The patient associated with the reported event did not survive, however the health care provider involved stated that they do not believe the device use contributed to the patient outcome.

• Brand Name: LIFEPAK® 20 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: 14777449
• Report Number: 0003015876-2022-01259
• Device Sequence Number: 5936328
• Product Code: MKJ
• UDI-Device Identifier: 00883873832622
• UDI-Public: 00883873832622
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000048
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 WK
• Patient Sex: Unknown