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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Physio-control contacted the customer in order to obtain additional information about the patient and event; however, no additional information was provided.
 
Event Description
The customer contacted physio-control to report that their device had illuminated its service led and indicates abnormal shock.In this state, the device may not be able to provide defibrillation therapy, if it were needed.
 
Event Description
The customer contacted physio-control to report that their device had illuminated its service led and indicates abnormal shock.In this state, the device may not be able to provide defibrillation therapy, if it were needed.
 
Manufacturer Narrative
Physio-control further evaluated the replaced ui pcba and system pcba at the product analysis center (pac) and no defect were found, both boards are functional.The cause of the reported issue could not be determined.
 
Manufacturer Narrative
A third party service provider evaluated the customer's device and verified reported issue.The user interface pcb and system pcb were replaced.The device passed functional and performance inspection and was returned to the customer.The third party service provider was contacted numerous times for component return, no response has been received.The components have not been returned to stryker for evaluation.The cause of the reported issue could not be determined.
 
Event Description
The customer contacted physio-control to report that their device had illuminated its service led and indicates abnormal shock.In this state, the device may not be able to provide defibrillation therapy, if it were needed.
 
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Brand Name
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key9744970
MDR Text Key190960177
Report Number0003015876-2020-00251
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Date Manufacturer Received06/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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