MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Model Number 20

Device Problem Inaccurate Synchronization (1609)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control provided the customer, a biomedical engineer, with technical assistance.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer, a biomedical engineer, contacted physio-control to report that while completing a performance inspection procedure (pip) on their device, that the time to deliver energy was consistently greater than 60 milliseconds when attempting synchronized cardioversion.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.There was no patient use associated with the reported event.

Manufacturer Narrative

It was later confirmed by the customer, a biomedical engineer, that their device will not be repaired and has been permanently removed from service.The device has not been returned to physio-control for evaluation.The cause of the reported issue could not be determined.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer Contact: yuchol kim ; 4258674000
• MDR Report Key: 5515290
• MDR Text Key: 40833510
• Report Number: 3015876-2016-00324
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• 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,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 3202487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/05/2016
• Date Device Manufactured: 02/04/2008
• 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