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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 05/15/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the reported issue. Physio replaced the therapy pcb assembly. 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.
 
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 logged an event code in the device¿s memory that is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of a portion of the biphasic output waveform, resulting in a monophasic shock. Additionally, the defibrillator output energy may be reduced by up to approximately 20% from the selected energy level. As a result, the wrong defibrillation therapy would be delivered, if it were necessary. 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 Key12073227
MDR Text Key258657792
Report Number0003015876-2021-01301
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001958
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2015
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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