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

Model Number	1000
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio determined that the cause of the reported issue was that a zip tie on the therapy wiring harness had been incorrectly placed over an integrated circuit (ic) chip, designator u1, on the analog pcb assembly.The pressure caused by this misplacement crushed the legs on one side of ic chip u1 and damaged resistor, designator r212.The customer received a replaced device.
Event or Problem Description
The customer contacted physio-control to report a non-critical failure 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 would not complete a charge when attempting to deliver a test shock.The device almost reached full charge when an arc was heard.As a result, defibrillation therapy would not be available, 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: 7629444
• Report Number: 0003015876-2018-00993
• Device Sequence Number: 1861358
• Product Code: MKJ
• UDI-Device Identifier: 00885074698878
• UDI-Public: 00885074698878
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/22/2018

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: 05/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1