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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 Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer, a biomedical engineer, advised that upon evaluation of their device he 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, a biomedical engineer, contacted physio-control to report that their device locked up during an event. The device was to be used in the cath lab and it powered on/off without issue, but was otherwise unresponsive when buttons were pressed. There were no reports of adverse effects to the patient as a result of the reported issue. Physio-control contacted the customer in an effort to obtain additional information about both the patient and the event. Physio-control was advised that no further details are available.
 
Manufacturer Narrative
It was later confirmed by the customer, a biomedical engineer, that after observing proper device operation through functional and performance testing the device was placed back into service for use. 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, a biomedical engineer, contacted physio-control to report that their device locked up during an event. The device was to be used in the cath lab and it powered on/off without issue, but was otherwise unresponsive when buttons were pressed. There were no reports of adverse effects to the patient as a result of the reported issue. Physio-control contacted the customer in an effort to obtain additional information about both the patient and the event. Physio-control was advised that no further details are available.
 
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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
Manufacturer (Section G)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer Contact
meg marseglia
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key7614120
MDR Text Key111705374
Report Number0003015876-2018-00962
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number97402-000002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/17/2003
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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