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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.
 
Event Description
A third party biomedical engineer contacted physio-control to report that a customer's device will not complete the boot-up process. There was no patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue. It was observed that the system pcb/interface pcb flex cable, designator w04, was slightly unseated from the system pcb at connector, designator j2. The system pcb assembly and the system pcb/interface pcb flex cable were replaced, and then proper device operation was observed through functional and performance testing. Other unrelated repairs were completed and the device was returned to the customer for use. Physio-control further evaluated the removed system pcb assembly and determined that the cause for the reported issue was due to physical wear on connector, designator j2.
 
Event Description
A third party biomedical engineer contacted physio-control to report that a customer's device will not complete the boot-up process. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK® 15 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 Key7611385
MDR Text Key111438784
Report Number0003015876-2018-00954
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001255
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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