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

Catalog Number	99400-002492
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control performed an initial evaluation of the customer's device and was unable to duplicate 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
The customer contacted physio-control to report that when attempting to use their device on a patient, the device would not power on.The customer advised that the patient did not survive the event; however, they do not believe that the device use contributed to the patient's outcome because the patient's heart rhythm was in pulseless electrical activity (pea).A backup device was also available during the event, but the customer did not indicate whether or not the backup device was used to treat the patient.
Additional Manufacturer Narrative
Physio-control downloaded the electronic patient records from the reported event for review.Upon review of the electronic records, physio-control was still unable to verify the reported issue.Physio-control did observe that there were 3 low battery messages in the record, indicating that the batteries installed in the device were low during the event.The cause of the reported issues could not be conclusively determined.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that when attempting to use their device on a patient, the device would not power on.The customer advised that the patient did not survive the event; however, they do not believe that the device use contributed to the patient's outcome because the patient's heart rhythm was in pulseless electrical activity (pea).A backup device was also available during the event, but the customer did not indicate whether or not the backup device was used to treat the patient.

• 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: 8458347
• Report Number: 0003015876-2019-00532
• Device Sequence Number: 2887596
• Product Code: MKJ
• UDI-Device Identifier: 00885074269498
• UDI-Public: 00885074269498
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 99400-002492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 79