• 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(R) 20E DEFIBRILLATOR/MONITOR 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(R) 20E DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20E
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Manufacturer Narrative
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
The customer contacted physio-control to report that their device was unable to detect the hard paddles assembly. The customer advised, "device alerting paddles not detected". In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed. There was no patient use associated with the reported event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIFEPAK(R) 20E 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 Key12436205
MDR Text Key270792877
Report Number0003015876-2021-01718
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
Report Date 09/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20E
Device Catalogue Number99507-000002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/28/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-