MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Failure To Run On AC/DC (1001)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the device but could not reproduce the reported issue.From the downloaded electronic data files and key log files, it was observed that the device had inappropriately lost power one time during the reported event.The electronic device files also indicate that one defibrillation charge was not delivered.Physio continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that their device powered off after charging defibrillation energy during a test with the device.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control further evaluated the device, but could not reproduce the reported issue.No discrepancies were observed during testing.The batteries and battery pins were replaced as part of the regular maintenance schedule.Proper device operation was confirmed through functional and performance testing.The device was returned to the customer.A cause of the reported issue could not be determined.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer Contact: todd bandy
• MDR Report Key: 7156232
• MDR Text Key: 96128379
• Report Number: 3015876-2017-01674
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-000887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: No
• Device Age: 3 YR
• Event Location: Other
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2014
• 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