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 07/28/2014

Event Type  malfunction  

Manufacturer Narrative

Correction information: the initial medwatch report did not include the evaluation of the device performed by physio-control, which was available at the time of the submission.The device arrived for evaluation on (b)(4) 2014.Physio-control evaluated the device and verified the reported failure.Physio replaced the system controller and user interface pcb assemblies and observed proper device operation through functional and performance testing.The device was then returned to the customer for use.Supplemental information: the removed pcb assemblies were further evaluated in the failure analysis center.The cause of the reported failure was determined to be a shorted integrated circuit chip, designator u61.Pin 23 of the ic chip had a 45 ohm short to ground.

Event Description

The customer reported that their device would not complete its boot up cycle when powering the device on.This was discovered during testing and there was no patient use associated with the reported failure.

Manufacturer Narrative

(b)(4).The hospital biomed has performed an evaluation on the device and verified the reported failure.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.

• 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: 4028664
• MDR Text Key: 12374357
• Report Number: 3015876-2014-00968
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 9 YR
• Event Location: Hospital
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2005
• 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