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

Model Number 20

Device Problems Overheating of Device (1437); Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

It was reported to physio-control that the customer had used their device to provide external pacing to a patient.After approximately 30 minutes, it was observed that there was smoke coming from the device and that the device was very hot.The device was then turned off, and a back-up device was used to continue treatment.It was also reported that the device was working until it had been switched off.Physio-control observed during device evaluation that the device would not power on with either ac or dc power.There was patient use associated with the reported event however, the patient outcome was not reported.

Manufacturer Narrative

Physio-control evaluated the device and verified the reported failure.It was observed that the power pcb showed burn marks.Physio-control then replaced the power module assembly.Proper device operation was observed through functional and performance testing.Following repair, the device was returned to the customer for use.

Manufacturer Narrative

Physio-control further evaluated the removed power module assembly (power supply assembly and power pcb assembly).Physio-control determined that the cause of the reported failure was due to a metal oxide varistor, designator mv3 on the power supply assembly that had shorted which caused the device not to have any 12 volt output and no battery charge.The power pcb assembly had smoke damage, but functioned properly.

• 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: 4142822
• MDR Text Key: 4913868
• Report Number: 3015876-2014-01163
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• 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: 3202488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 6 YR
• Event Location: Hospital
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2008
• 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
• Patient Age: 70 YR