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 12/18/2013

Event Type  malfunction  

Event Description

The customer, a biomed, contacted physio-control to report that pin 8 from a standard hard paddles assembly had broken off and become lodged in receptacle 8 of their device's therapy connector assembly.As a result, the charge button on the hard paddles was disabled and defibrillation therapy was not possible.There was no patient use associated with the reported event.

Manufacturer Narrative

The initial medwatch report indicates: the customer, a biomed, contacted physio-control to report that a pin from a standard hard paddles assembly had broken off and become lodged in their device's therapy connector assembly.As a result, defibrillation may not be able to be delivered.There was no patient use associated with the reported event.The initial medwatch report should indicate: the customer, a biomed, contacted physio-control to report that pin 8 from a standard hard paddles assembly had broken off and become lodged in receptacle 8 of their device's therapy connector assembly.As a result, the charge button on the hard paddles was disabled and defibrillation therapy was not possible.There was no patient use associated with the reported event.

Event Description

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

Manufacturer Narrative

(b)(4).Physio-control provided the customer with the part number and pricing for both a replacement standard hard paddle assembly as well as a therapy connector assembly.It was later confirmed by the customer that he had replaced both the therapy connector assembly as well as the standard hard paddles assembly.After observing proper device operation through functional and performance testing the unit was placed back into service for work.Neither the device, nor the original standard hard paddles, 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: 3575309
• MDR Text Key: 4498878
• Report Number: 3015876-2014-00040
• 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,Followup
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• 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: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2004
• 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