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U.S. Department of Health and Human Services

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

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATIC EXTERNAL DEFIBRILLATOR (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problems Failure to Charge (1085); Electrical /Electronic Property Problem (1198); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Loss Of Pulse (2562); No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2019
Event Type  malfunction  
Manufacturer Narrative
Physio-control continues to investigate the reported failure 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 their device did not charge and would not respond to pressed buttons. In this state the device would be inoperable and defibrillation therapy would not be available if needed. The incident is patient related. The customer was unable to provide any patient information due to confidentiality concerns, but reported that the patient was in asystole throughout the event and did not present with a shockable rhythm at any stage of the event.
 
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Brand NameLIFEPAK® 15 DEFIBRILLATOR/MONITOR
Type of DeviceAUTOMATIC EXTERNAL DEFIBRILLATOR (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 Key9312879
MDR Text Key173907695
Report Number0003015876-2019-01827
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K142430
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 12/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-000013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2009
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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