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

Catalog Number	99400-002505
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
The customer contacted physio-control to report that their device displays "service" across the display during patient use.This issue is indicative of a device lock-up condition that could delay or prevent defibrillation if it were necessary.There were no reports of adverse effects as a result of the reported issue.Physio-control has made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event; however, no response has been received.
Additional Manufacturer Narrative
The customer advised physio-control that they were able to resolve their issue with their device.The device was not returned to physio for an evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device displays "service" across the display during patient use.This issue is indicative of a device lock-up condition that could delay or prevent defibrillation if it were necessary.There were no reports of adverse effects as a result of the reported issue.Physio-control has made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event; however, no response has been received.

• Brand Name: LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
• 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: 8574403
• Report Number: 0003015876-2019-00766
• Device Sequence Number: 16206810
• Product Code: MKJ
• UDI-Device Identifier: 00885074269252
• UDI-Public: 00885074269252
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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 Catalogue Number: 99400-002505
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1