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: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
  • 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
 

COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 980
Medical Device Problem Code Erratic or Intermittent Display (1182)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/23/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that, while in use on a patient the screen on a 980 ventilator reset and then became erratic.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the event.The service engineer (se) inspected the device and was not able to duplicate the reported condition.The ventilator was run on a test lung for 48 hours without incident.The ventilator passed extended self-testing and no parts were replaced.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
980 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
MDR Report Key6745054
Report Number8020893-2017-07126
Device Sequence Number590455
Product Code CBK
UDI-Device Identifier10884521171749
UDI-Public10884521171749
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K131252
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number980
Device Catalogue Number980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/27/2017
Initial Report FDA Received Date07/26/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-