MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 10 DEFIBRILLATOR/MONITOR/PACEMAKER; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 10

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2014

Event Type  malfunction  

Manufacturer Narrative

Despite several attempts from physio-control to get the device returned, the customer did not return the device for further evaluation.Since the device was not returned for evaluation, a cause of the reported failure could not be determined.Physio-control discontinued service and support of this device as of (b)(6) 2010.The customer was therefore advised to replace their device due to its age and the lack of service and support for this device.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The device was not returned to physio-control for evaluation.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer reported to physio-control that their device was overheating, and caught fire.The device was connected to ac power.When the device was unplugged from ac power, it cooled down but it would heat up again, as soon as it was connected back to ac power.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 10 DEFIBRILLATOR/MONITOR/PACEMAKER
• 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: 3822714
• MDR Text Key: 12049362
• Report Number: 3015876-2014-00577
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K890079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 10
• Device Catalogue Number: 804200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 18 YR
• Event Location: Other
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/1996
• 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