Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 QUIK COMBO; ELECTRODE, ELECTROCARDIOGRAPH
  • 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 QUIK COMBO; ELECTRODE, ELECTROCARDIOGRAPH Back to Search Results
Model Number 11996
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2022
Event Type  malfunction  
Event Description
The customer contacted stryker to report that their defibrillation electrodes were not connecting to their device properly.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There was no report of patient use associated with the reported event.
 
Manufacturer Narrative
The electrodes were not returned to stryker for evaluation.The cause of the reported issue could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUIK COMBO
Type of Device
ELECTRODE, ELECTROCARDIOGRAPH
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 Key14253964
MDR Text Key290420765
Report Number0003015876-2022-00638
Device Sequence Number1
Product Code DRX
UDI-Device Identifier00883873784938
UDI-Public00883873784938
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11996
Device Catalogue Number11996-000090
Device Lot Number132194
Was Device Available for Evaluation? No
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
LIFEPAK® 15 DEFIBRILLATOR/MONITOR, MKJ
-
-