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

Catalog Number	99400-000372
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
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, a biomedical engineer contacted physio-control to report that their device charged to an incorrect energy level.The customer advised that the device was charged to 200 joules, however the energy charge only would go up to 50 joules.Advised that their device service indicator had illuminated when the defibrillation electrodes were connected to the patient.In this state, inadequate or wrong defibrillation therapy would be delivered to the patient.This issue is patient related; however there was no adverse patient outcome reported.No further details were provided by the customer.Physio-control contacted the customer in order to obtain additional information about both the patient and the event, however, the customer was unable provide further information.
Event or Problem Description
The customer, a biomedical engineer contacted physio-control to report that their device charged to an incorrect energy level.The customer advised that the device was charged to 200 joules, however the energy charge only would go up to 50 joules.Advised that their device service indicator had illuminated when the defibrillation electrodes were connected to the patient.In this state, inadequate or wrong defibrillation therapy would be delivered to the patient.This issue is patient related; however there was no adverse patient outcome reported.No further details were provided by the customer.Physio-control contacted the customer in order to obtain additional information about both the patient and the event, however, the customer was unable provide further information.
Additional Manufacturer Narrative
The device was returned for evaluation therefore, section d10 "returned to manufacturer on" has been updated accordingly with the new information.Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio downloaded the electronic records from the customer¿s device and was unable to confirm the reported issue.The cause of the reported issue could not be conclusively determined.

• 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: 8130746
• Report Number: 0003015876-2018-02047
• Device Sequence Number: 1487025
• Product Code: MKJ
• UDI-Device Identifier: 00721902148460
• UDI-Public: 00721902148460
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 99400-000372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1