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

MAUDE Adverse Event Report: GE HEALTHCARE/ DATEX-OHMEDA, INC. CARESCAPE R860; 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
 

GE HEALTHCARE/ DATEX-OHMEDA, INC. CARESCAPE R860; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number SN1-511273564790
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Hypoxia (1918)
Event Date 12/19/2020
Event Type  Injury  
Event Description
During bathing ventilator alarmed patient disconnect.No disconnections found.Patient hypoxic, pea.Acls done.Ventilator found not to be ventilating patient at all time.Plugged in and never lost power.Removed from patient care.Biomed on site 12/21/20 and completed inspection on this and 2 other similar ventilators.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARESCAPE R860
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
GE HEALTHCARE/ DATEX-OHMEDA, INC.
MDR Report Key11260698
MDR Text Key230091860
Report NumberMW5099110
Device Sequence Number1
Product Code CBK
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/29/2020
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSN1-511273564790
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age74 YR
Patient Weight79
-
-