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

Model Number 15

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control for evaluation.The device will be sent to a third-party service agent.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

It was reported to physio-control that the customer's device would not power on.The device was powered with ac, but wouldn't charge its batteries.The battery led was off and the auxiliary led flashed.After all the cables were disconnected and reconnected, the device started charging the batteries again.It was not reported if there was any patient use associated with the reported event.

Manufacturer Narrative

The device was eventually returned to physio-control.Physio evaluated the device but could not reproduce the reported issue.The device was extensively tested without observing any discrepancies.As soon as proper device operation has been confirmed through functional and performance testing, the device will be returned to the customer.A cause of the reported issue could not be confirmed.

• 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: 7156241
• MDR Text Key: 96119175
• Report Number: 3015876-2017-01677
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

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: 99577-001394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 YR
• Event Location: Other
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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