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

Catalog Number	99400-002497
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio observed that the therapy connection sensing cable was disconnected from the therapy pcb assembly.Physio reconnected the sensing cable to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device was not detecting the paddles lead.As a result, defibrillation therapy may be unavailable, if it is needed.There was no report of patient use associated with the reported event.

• 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: 9221725
• Report Number: 0003015876-2019-01737
• Device Sequence Number: 11308471
• Product Code: MKJ
• UDI-Device Identifier: 00885074269542
• UDI-Public: 00885074269542
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• 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): 10/22/2019

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: 99400-002497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1