MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the therapy cable which resolved the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.

Event Description

Physio-control was performing preventative maintenance on the customer's device and observed that the therapy cable was intermittently connecting to the device.It was a very loose connected and the device would lose the ecg signal if the cable was moved.As a result, defibrillation therapy may not be available, if it was needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: megan marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 7679897
• MDR Text Key: 113747091
• Report Number: 0003015876-2018-01085
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• 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: 99577-001255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2013
• 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