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

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was unable to provide any further information for the event or the patient.Physio-control evaluated the customers device and was unable to duplicate the reported issue.Physio replaced the device's battery pcb assembly as a precaution and after unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device beeped and the battery indicator flashed repeatedly, then it spontaneously shut off on three occasions during a case.They said they were able to use it for one blood pressure, then it shut off, then they turned it on again and were able to use it for a second set of vitals.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of any adverse effect to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Physio-control reviewed the device electronic data and verified the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device beeped and the battery indicator flashed repeatedly, then it spontaneously shut off on three occasions during a case.They said they were able to use it for one blood pressure, then it shut off, then they turned it on again and were able to use it for a second set of vitals.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of any adverse effect to the patient as a result of the reported issue.

• Brand Name: LIFEPAK® 15 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: 10043601
• Report Number: 0003015876-2020-00627
• Device Sequence Number: 16875090
• Product Code: MKJ
• UDI-Device Identifier: 00883873872048
• UDI-Public: 00883873872048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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: UNK_SMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 84