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

Model Number 20

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2014

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that their device had a service indicator present.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that the unit would constantly reboot itself upon power on and never complete the boot up cycle.

Manufacturer Narrative

Physio-control examined the customer's device and verified the reported issue.Physio then replaced the therapy pcb assembly, as well as made other unrelated repairs, and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio further evaluated the removed therapy pcb assembly and determined that the cause of the reported issue was an integrated circuit (ic) chip, (b)(4) was temperature sensitive (heat).

• 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: 4110244
• MDR Text Key: 4836458
• Report Number: 3015876-2014-01108
• 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: 08/25/2014

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2003
• 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