MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 11130-000001

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer, a biomedical engineer, evaluated the device and verified the reported issue.The customer confirmed that the hard paddles had a broken pin in the connector.The hard paddles were replaced which resolved the reported issue.The customer confirmed that the damaged hard paddles were disposed of.After observing proper device operation through functional and performance testing, the device was returned for use.The device was not returned to physio-control for evaluation.Device not evaluated by manufacturer.

Event Description

The customer contacted physio-control to report that the charge button on their hard paddles was not functioning.The customer observed a broken pin on the connector of the hard paddles.As a result, defibrillation therapy would not be able to be delivered, if it were necessary.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
• 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: jason march ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 7366841
• MDR Text Key: 103551756
• Report Number: 0003015876-2018-00469
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11130-000001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2001
• 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