• 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
Event Date 09/17/2020
Event Type  malfunction  
Manufacturer Narrative
The customer has submitted voluntary event report mw5096816 regarding this event.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 would not sense rhythm or heart rate while quik-combo electrodes were in use.There was no patient use reported with the event.
 
Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information, and it has been added to section a.Patient fields in which information is not provided were intentionally left blank.  additionally, the device serial number was added to section d10.
 
Event Description
The customer contacted physio-control to report that their device would not sense rhythm or heart rate while quik-combo electrodes were in use.There was no patient use reported with the event.
 
Event Description
The customer contacted physio-control to report that their device would not sense rhythm or heart rate while quik-combo electrodes were in use.There was no patient use reported with the event.
 
Manufacturer Narrative
The customer informed physio-control that the issue has been resolved, and the device does not need to be returned for further evaluation.The reported issue was unable to be verified and unable to be duplicated.Root cause is unable to be determined.H3 other text: device not returned.
 
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
MDR Report Key10818085
MDR Text Key215572779
Report Number0003015876-2020-01687
Device Sequence Number1
Product Code DRX
UDI-Device Identifier00883873784945
UDI-Public00883873784945
Combination Product (y/n)N
PMA/PMN Number
K943301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11996
Device Catalogue Number11996-000091
Device Lot Number4828
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/16/2020
Initial Date FDA Received11/10/2020
Supplement Dates Manufacturer Received11/10/2020
08/16/2021
Supplement Dates FDA Received11/12/2020
08/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LIFEPAK 20 DEFIBRILLATOR/MONITOR, MKJ, SN (B)(6); LIFEPAK DEFIBRILLATOR/MONITOR, MKJ; LIFEPAK DEFIBRILLATOR/MONITOR, MKJ
Patient Age60 YR
-
-