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

Catalog Number	99400-000001
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer, a biomedical engineer, evaluated the device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned for use.The device was not returned to physio-control for an evaluation.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 they were using this device on a patient and when they switched it into manual mode the device kept going back into aed mode.As a result, manual defibrillation may have been unavailable or delayed, if it was needed.There was no report of any adverse effect to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.

• 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: 8576013
• Report Number: 0003015876-2019-00775
• Device Sequence Number: 291444
• Product Code: MKJ
• UDI-Device Identifier: 00721902144752
• UDI-Public: 00721902144752
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• 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: 99400-000001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1