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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 1000
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the reported issue. Physio determined that the cause of the reported issue was due to a broken solder joint on pin 8 of the h-bridge. A cable was pressing down on the h-bridge which resulted in the broken solder joint. The customer was sent a replacement device.
 
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 when attempting to shock into a simulator. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK(R) 1000 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 Key11391891
MDR Text Key234010511
Report Number0003015876-2021-00494
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873815458
UDI-Public00883873815458
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122600
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
Report Date 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000
Device Catalogue Number99425-000023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2017
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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