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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the reported issue. Physio observed that the defibrillation therapy cable assembly was damaged. The customer will replace the cable. After observing proper device operation through functional and performance testing, the device will be returned to the customer for use.
 
Event Description
The customer contacted physio-control to report that their device was unable to provide a reading through the defibrillation therapy electrodes. In this state, the device would be inoperable and defibrillation therapy would not be available if needed. There was no report of patient use for the reported event.
 
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Brand NameLIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
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 Key12284321
MDR Text Key265396745
Report Number0003015876-2021-01531
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001955
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2017
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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