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

Model Number 20

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 01/02/2014

Event Type  malfunction  

Event Description

The customer, a biomed, contacted physio-control to report that their device was displaying the service indicator.The biomed advised that his test equipment was unable to distinguish the difference between a monophasic shock or a biphasic shock, but that his equipment had indicated that there was a partial loss of defibrillator output energy.The energy had been reduced approximately 18% from the selected energy level.There was no report of patient use associated with the reported issue.

Manufacturer Narrative

(b)(4): physio-control provided the biomed with troubleshooting assistance and provided the biomed with a quote for physio to examine the device.Physio was later advised by the biomed that he had provided the customer with the service quote, but is currently awaiting authorization before he can proceed.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.

Manufacturer Narrative

Physio-control contacted the biomedical engineer who advised that a decision has not been made on if, or when, the customer's device will be repaired.The biomedical engineer was unable to provide a time line regarding when a decision on what to do with the device may be available.The device has not been returned to physio-control for evaluation.The cause of the reported failure could not be determined.

• 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: 3593683
• MDR Text Key: 4190039
• Report Number: 3015876-2014-00068
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/02/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 7 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 01/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2006
• 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