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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 1000
Device Problems Unintended Power Up (1162); Electrical /Electronic Property Problem (1198); Failure to Shut Off (2939)
Patient Problem No Patient Involvement (2645)
Event Date 10/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control evaluated the customers device and verified the reported issue.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
The customer contacted physio-control to report that their device unexpectedly power up when the battery was inserted they were unable to turn the device off.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient use reported with the event.
 
Event Description
The customer contacted physio-control to report that their device unexpectedly power up when the battery was inserted they were unable to turn the device off.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient use reported with the event.
 
Manufacturer Narrative
Physio-control replaced the device's battery contact pcb assembly to resolve the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the removed battery contact pcb assembly and no further root cause could be determined.
 
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Brand Name
LIFEPAK® 1000 DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key9282824
MDR Text Key190344599
Report Number0003015876-2019-01803
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873815458
UDI-Public00883873815458
Combination Product (y/n)N
PMA/PMN Number
K122600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1000
Device Catalogue Number99425-000023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2019
Date Manufacturer Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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