MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 12 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	N/A
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customers device and verified the reported issue.Physio-control 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.
Event or Problem Description
Upon evaluation of the customer's device, physio-control observed that the device would power itself down a few seconds after being turned on.Patient involvement was not reported.
Additional Manufacturer Narrative
The device is no longer serviceable so was returned unrepaired to the customer, and root cause could not be determined.
Event or Problem Description
Upon evaluation of the customer's device, physio-control observed that the device would power itself down a few seconds after being turned on.Patient involvement was not reported.

• Brand Name: LIFEPAK 12 DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11499677
• Report Number: 0003015876-2021-00577
• Device Sequence Number: 19957568
• Product Code: MKJ
• UDI-Device Identifier: 00885074857749
• UDI-Public: 00885074857749
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2021

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: N/A
• Device Catalogue Number: 99400-003505
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 08/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1