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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Material Fragmentation (1261)
Patient Problem No Patient Involvement (2645)
Event Date 05/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control continues to investigate the reported issue 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 a pin had broken off from the standard hard paddles accessory of their device.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no patient use associated with the reported event.
 
Event Description
The customer contacted physio-control to report that a pin had broken off from the standard hard paddles accessory of their device.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.It was observed that a broken pin from the standard hard paddles assembly was stuck in the device's therapy connector.After removing the broken pin and performing some other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use, and the customer was provided with a new set of standard hard paddles.
 
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Brand Name
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key8693745
MDR Text Key147859411
Report Number0003015876-2019-01031
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/04/2019
Date Manufacturer Received07/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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