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

Model Number	15
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/05/2019
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 a service indicator present and an event code in its memory which indicates that the aed function of the device may be inoperable and, as a result, the unit may not be able to analyze a patient's rhythm and provide defibrillation therapy while in aed mode if it were necessary.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Method code, of the initial medwatch report indicated: blank method code, of the initial medwatch report should have indicated: analysis of data provided by user/third party (4112).Results code, of the initial medwatch report indicated: blank results code, of the initial medwatch report should have indicated: results pending completion of investigation (3233).Conclusion code, of the initial medwatch report indicated: blank conclusion code, of the initial medwatch report should have indicated: conclusion not yet available (11).Additional mfg narrative, of the initial medwatch report indicated: code # 2645 - na.Code # 1539 - unlabeled.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.Additional mfg narrative, of the initial medwatch report should have indicated: code # 2645 - na.Code # 1539 - unlabeled.The customer, a biomedical engineer, evaluated the device and verified the reported issue.Despite clearing the event code in the device's memory, it would return.Physio-control provided the customer, a biomedical engineer, with technical assistance and recommended that the device be sent to physio-control for repair.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.New information for supplemental medwatch report: the customer later contacted physio-control to advise that they will not be sending their device to physio-control for repair.The device was not returned to physio-control.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 had a service indicator present and an event code in its memory which indicates that the aed function of the device may be inoperable and, as a result, the unit may not be able to analyze a patient's rhythm and provide defibrillation therapy while in aed mode if it were necessary.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 8491625
• Report Number: 0003015876-2019-00605
• Device Sequence Number: 2015144
• Product Code: MKJ
• UDI-Device Identifier: 00883873979419
• UDI-Public: 00883873979419
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 05/08/2019

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 Model Number: 15
• Device Catalogue Number: 99577-000056
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1