• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 1000 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 1000 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 1000
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customers device and verified the reported issue. 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 a non-critical issue with their device. There was no report of patient use associated with the reported event. During evaluation by physio-control the device displayed the error "abnormal energy delivery". In this state the device may not be able to deliver defibrillation therapy if needed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIFEPAK 1000 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 Key10928234
MDR Text Key218958341
Report Number0003015876-2020-01799
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122600
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 02/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000
Device Catalogue Number99425-000023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-