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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Catalog Number 99400-000416
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control evaluated the customer's device and was unable to duplicate the reported issue. After other unrelated repairs were completed, proper device operation was observed through functional and performance testing. The device was returned to the customer for use. The cause of the reported issue could not be determined.
 
Event Description
The customer contacted physio-control to report that their device froze while they were using it to monitor a patient and they were not able to perform any functions on the device. As a result, defibrillation therapy would have been unavailable, if it was needed. They powered the device off and back on and the issue went away and they were able to continue using the device on the patient. There were no reports of adverse effects to the patient as a result of the reported issue.
 
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Brand NameLIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer (Section G)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer Contact
megan marseglia
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key7636130
MDR Text Key112292799
Report Number0003015876-2018-01016
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number99400-000416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2001
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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