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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Catalog Number 99400-000814
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2020
Event Type  malfunction  
Manufacturer Narrative
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 stryker to report that the sync time on their device would sometime exceed the upper limit of 60 milliseconds.A sync delay exceeding 60 milliseconds may deliver the synchronized cardioversion on the t-wave, which could cause a patient to go into ventricular fibrillation.There was no patient use associated with the reported event.
 
Manufacturer Narrative
A third-party service agent evaluated the customer's device and verified the reported issue.After replacing the therapy pcb assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
 
Event Description
The customer contacted stryker to report that the sync time on their device would sometime exceed the upper limit of 60 milliseconds.A sync delay exceeding 60 milliseconds may deliver the synchronized cardioversion on the t-wave, which could cause a patient to go into ventricular fibrillation.There was no patient use associated with the reported event.
 
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Brand Name
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key10131590
MDR Text Key194508804
Report Number0003015876-2020-00730
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K102972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number99400-000814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2020
Date Manufacturer Received10/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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