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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Catalog Number UNK_SMP
Device Problem Material Fragmentation (1261)
Patient Problem No Patient Involvement (2645)
Event Date 12/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the device's therapy connector and therapy cable.After 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 that the device quik-combo therapy cable pins broke in the therapy connector.As a result, defibrillation may not have been possible if it were necessary.There was no patient use associated with the reported issue.
 
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Brand Name
LIFEPAK® 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
Manufacturer (Section G)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer Contact
meg marseglia
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key8217207
MDR Text Key132073179
Report Number0003015876-2019-00024
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
Reporter Occupation Other
Type of Report Initial
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Date Manufacturer Received12/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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