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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problems Connection Problem (2900); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
The device reached its end of life on 12/23/2020 and physio was unable to evaluate the device. The customer's therapy cable which was in use at the time of the event was evaluated. One on the pins was visibly broken off and the date code on the cable was 5/2003. The recommended replacement for this cable per the service manual is every 3 years. This cable was connected to another lp20 and the customer's complaint was duplicated. The customer was informed of recommended replacement on the cable.
 
Event Description
The customer contacted physio-control to report that their device failed to detect attachment to the patient. This issue is patient related; however there was no adverse event reported.
 
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Brand NameLIFEPAK 20 DEFIBRILLATOR/MONITOR
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 Key11363768
MDR Text Key234430614
Report Number0003015876-2021-00445
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number99402-000065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2008
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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