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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 Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A biomedical engineer for the hospital evaluated their device and was unable to duplicate the reported issue. 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.
 
Event Description
The customer contacted physio-control to report that their device displayed a white screen during the user test. This is an indication that the device may be inoperable and defibrillation therapy would not be available if needed. There was no patient use associated with the reported event.
 
Manufacturer Narrative
The customer, a biomedical engineer confirmed that their device was removed from service and replaced with another device. The device was not returned to physio-control for evaluation. The cause of the reported issue could not be determined. Device not evaluated by manufacturer.
 
Event Description
The customer contacted physio-control to report that their device displayed a white screen during the user test. This is an indication that the device may be inoperable and defibrillation therapy would not be available if needed. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key7593465
MDR Text Key110846432
Report Number0003015876-2018-00919
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 company representative
Type of Report Initial,Followup
Report Date 08/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number99402-000016
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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