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U.S. Department of Health and Human Services

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

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the reported issue. Physio replaced the therapy pcb assembly. Other unrelated repairs were completed and proper device operation was observed through functional and performance testing. The device will be returned to the customer for use.
 
Event Description
The customer contacted physio-control to report a non-critical issue with their device. Upon evaluation of the customer¿s device, physio-control observed that the device displayed an ¿abnormal energy¿ message. In this state, wrong defibrillation therapy may be delivered to the patient. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
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
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key12053429
MDR Text Key258039439
Report Number0003015876-2021-01276
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001219
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2014
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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