MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Catalog Number 3005400

Device Problem Invalid Sensing (2293)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

During a regularly scheduled preventative maintenance, physio-control observed that the customer's monophasic aed device would constantly alarm, stating that motion was detected, when attached to a patient simulator.As a result, defibrillation would not be possible because a patient rhythm could not be analyzed.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4).Physio-control examined the customer's device and verified the reported issue.Physio advised the customer that their monophasic aed device is no longer supported by physio and, as a result, the device is no longer serviceable.Physio recommended that the device be permanently removed from service and a replacement be obtained.The cause of the reported issue could not be determined.

• Brand Name: LIFEPAK(R) 500 AUTOMATED EXTERNAL 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: 4491779
• MDR Text Key: 18030631
• Report Number: 3015876-2015-00126
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3005400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Device Age: 16 YR
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/1998
• 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