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

Catalog Number	99400-003486
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control 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 physio-control to report that their device had displayed a "service" message in its display.This message can be indicative of a device lock-up condition.As a result, defibrillation therapy may not be available, if it is needed.There were no reports of patient use associated with the reported event.
Additional Manufacturer Narrative
The device was not returned to physio-control for evaluation.A third-party service agent performed an initial evaluation of the customer's device and verified the reported issue.Additionally, physio-control contacted the customer and confirmed that the date that the reported issue was observed was 12/05/2018.As a result, b3, event date, has been updated accordingly.Physio-control 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.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device had displayed a "service" message in its display.This message can be indicative of a device lock-up condition.As a result, defibrillation therapy may not be available, if it is needed.There were no reports of patient use associated with the reported event.
Additional Manufacturer Narrative
The third-party service agent replaced the system pcb assembly and subsequently observed proper device operation through functional and performance testing.The device was then returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device had displayed a "service" message in its display.This message can be indicative of a device lock-up condition.As a result, defibrillation therapy may not be available, if it is needed.There were no reports of patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 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: 8191559
• Report Number: 0003015876-2018-02178
• Device Sequence Number: 1900462
• Product Code: MKJ
• UDI-Device Identifier: 00885074855653
• UDI-Public: 00885074855653
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K102972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2019

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: 99400-003486
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 02/01/2019; 04/09/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/28/2019; 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1