MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Catalog Number 99400-003486

Device Problem Inaccurate Synchronization (1609)

Patient Problem No Patient Involvement (2645)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). physio-control provided the customer, a biomedical engineer, with technical assistance. the biomedical engineer examined the device and verified the reported issue. physio then advised the customer that their device is no longer supported by physio-control and therefore parts and service is no longer available. physio recommended that the device be permanently removed from service and that a replacement unit be obtained. it was later confirmed by the customer that the device has not been repaired and was removed from service.The device has not been returned to physio-control for evaluation.The cause of the reported issue could not be determined.

Event Description

The customer, a biomedical engineer, contacted physio-control to report that during an evaluation of their device it did not pass the standard paddles test. the biomedical engineer advised that there was a sync delay of 74 milliseconds during testing.There was no patient use associated with the reported event.Physio-control concluded that a sync delay exceeding 60 milliseconds may deliver the energy on the t-wave which could cause a patient to go into ventricular fibrillation.

• Brand Name: LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 4258674000
• MDR Report Key: 6885138
• MDR Text Key: 88443731
• Report Number: 3015876-2017-01175
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 99400-003486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 9 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/30/2017
• Date Device Manufactured: 07/23/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1