MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 20

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that a pin from a hard-paddles assembly had broken off and become lodged in the device's therapy connector assembly.As a result, defibrillation may not be available, if necessary.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4).Physio-control assisted the customer, a biomedical engineer, with ordering replacement therapy connector and hard-paddles assemblies.It was later confirmed by the biomed that he replaced the therapy connector and hard-paddles assemblies, and after observing proper device operation through functional and performance testing the unit was placed back into service for use.Neither the device, nor the hard-paddles assembly, have been returned to physio-control for evaluation.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 3723093
• MDR Text Key: 19198663
• Report Number: 3015876-2014-00352
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• 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: 3202487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 9 YR
• Event Location: Hospital
• Date Manufacturer Received: 03/06/2014
• Date Device Manufactured: 12/28/2004
• 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