MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 1000 DEFIBRILLATOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Model Number 1000

Device Problem Invalid Sensing (2293)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2014

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the device but could not duplicate the reported failure of excessive motion alarms.It was observed that the device would charge and shock defibrillation energy.Proper device operation was observed through functional and performance testing.An internal inspection of the device was performed without observing any discrepancies.

Event Description

It was reported to a physio-control service agent that the customer's device continuously gave the prompt 'motion detected'; also when there was no motion.Therefore the device would not provide an analysis of a patient's heart rhythm when required.There was no patient use associated with the reported event.

Manufacturer Narrative

A third-party service agent evaluated 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) 1000 DEFIBRILLATOR
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• 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: 3921108
• MDR Text Key: 12055191
• Report Number: 3015876-2014-00779
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K042404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 06/11/2014

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: Medical Technologist
• Device Model Number: 1000
• Device Catalogue Number: 3203715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 07/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1