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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
Model Number 12
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/24/2020
Event Type  malfunction  
Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient. No response has been received from the customer. Patient fields in which information is not provided were intentionally left blank. Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council. 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
A customer contacted physio-control to report that their device did not work during patient use. A back up device was available and was used to continue patient care. The device was later tested by the customer and it was observed that the defibrillation energy level was not as expected. As a result, wrong defibrillation therapy would have been delivered, if needed. There were no reports of adverse effects to the patient as a result of the reported event.
 
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Brand NameLIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
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 Key10423108
MDR Text Key203485376
Report Number0003015876-2020-01086
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number12
Device Catalogue Number99400-000077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2001
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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