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

Catalog Number	99400-000822
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer, a biomedical engineer, evaluated the device and verified the reported issue.(b)(6) provided the biomed with technical assistance.The customer determined that the cause of the reported issue was due to the damaged therapy connector on the device.Physio provided the customer with the therapy connector repair kit part number.The device was not returned to (b)(6) for an evaluation.
Event or Problem Description
The customer, a biomedical engineer, contacted (b)(6) to report that the therapy connector on their device is damaged and the therapy cable is difficult to attach to the device.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no patient use associated with the reported issue.

• 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: 8177054
• Report Number: 0003015876-2018-02145
• Device Sequence Number: 16508806
• Product Code: MKJ
• UDI-Device Identifier: 00721902152962
• UDI-Public: 00721902152962
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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 Catalogue Number: 99400-000822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1