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

Catalog Number 99400-000523

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control provided the customer, a biomedical engineer with technical assistance.The biomed reported to physio that he replaced the therapy connector which resolved the reported issue and the device is back in service.The device or the replaced therapy connector was not returned to physio-control for an evaluation.Device not evaluated by manufacturer.

Event Description

The customer, a biomedical engineer, contacted physio-control to report that he observed that there is a pin stuck inside of the therapy connector on their device.As a result, defibrillation therapy would not have been possible if it were necessary.There was no patient use associated with the reported issue.

• 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: 7384007
• MDR Text Key: 104043216
• Report Number: 0003015876-2018-00520
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 99400-000523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• 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