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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LIFEPAK 20 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. LIFEPAK 20 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)
Patient Problem Loss of consciousness (2418)
Event Date 09/27/2017
Event Type  malfunction  
Event Description
While the patient was being external paced at a hr of 80 with good capture and they were arranging a transfer to another facility when the family alerted the staff that the patient was unconscious. When the nurse went into the room, the hr was back at 20 and the machine was off. The machine was plugged in and returned to the rate of 80. The patient was put on another machine and this machine was pulled from service. There was an issue with the programming but it was difficult to recreate and there was a decision to send the device back to the company for investigation.
 
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Brand NameLIFEPAK 20
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC.
11811 willows rd. n.e.
redmond WA 98052
MDR Report Key6990101
MDR Text Key90661732
Report Number6990101
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/16/2017
Event Location Hospital
Date Report to Manufacturer10/16/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/31/2017 Patient Sequence Number: 1
Treatment
CARDIAC DRUGS; NONE THAT WOULD HAVE CONTRIBUTED TO THE EVENT.
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