MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	1000
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio-control also observed that the device was delivering monophasic energy rather than biphasic energy.The energy delivered by the device was also at a lower energy level than what was selected.The cause of the observed issue was determined to be due to a therapy harness ferrite bead being set over an integrated circuit, designator u1, in error during the manufacturing of the device.The incorrectly set therapy harness ferrite bead broke u1 legs 1 and 16 coming from the analog pcb assembly.U1 leg 16 no longer had a connection, which resulted in the device delivering a monophasic shock at a reduced energy level.The customer received a replacement device.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the device was delivering monophasic energy rather than biphasic energy.The energy delivered by the device was also at a lower energy level than what was selected.As a result, the incorrect defibrillation therapy may be delivered, if it was needed.

• Brand Name: LIFEPAK® 1000 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: 7942730
• Report Number: 0003015876-2018-01654
• Device Sequence Number: 2255492
• Product Code: MKJ
• UDI-Device Identifier: 00885074698878
• UDI-Public: 00885074698878
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 1000
• Device Catalogue Number: 99425-000023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1