MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control.A third-party service agent evaluated the customer's device and verified the reported issue.It was observed that a connector pin of the quik-combo cable had broken off and was stuck in the device's therapy connector.After replacing the therapy connector assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.Device not evaluated by manufacturer.

Event Description

The customer contacted physio-control to report that a connector pin had broken off and was stuck in the device's therapy connector.In this state the device may not be able to deliver therapy, if it were needed.There were no reports of patient use associated with the reported event.

Event Description

The customer contacted physio-control to report that a connector pin had broken off and was stuck in the device's therapy connector.In this state the device may not be able to deliver therapy, if it were needed.There were no reports of patient use associated with the reported event.

Manufacturer Narrative

The customer provided physio-control with the following new information: age - was updated to: 66 years.Gender - was updated to: m.Weight - was updated to: 109 kilograms.Event date - was updated to: 02/17/2019.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 8445303
• MDR Text Key: 139607898
• Report Number: 0003015876-2019-00500
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• 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: 99402-000017
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 109