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

Model Number 20

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that the paddle plates on a set of their hard-paddles assembly had detached from the assembly.As a result, the hard-paddles could not be used for defibrillation, if necessary.The hard-paddles were used in conjunction with a lifepak 20 defibrillator/monitor device; however, the biomedical engineer was unable to provide the serial number for the device that the paddles had been installed on.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4).The biomedical engineer advised physio-control that there was some damage to the hard-paddles assembly, but he could not be certain when or how the damage occurred, or if it contributed to the paddle plates detaching from the assembly.Physio then provided the customer with the part number for a replacement hard-paddles assembly.It was later confirmed by the biomedical engineer that he had received the replacement hard-paddles assembly and after observing proper operation through functional and performance testing the hard-paddles were placed into service for use.The original hard-paddles were disposed of by the biomedical engineer locally; therefore they were not 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: 3781028
• MDR Text Key: 4356465
• Report Number: 3015876-2014-00473
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 23621
• Other Device ID Number: 3200941-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/30/2014
• 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