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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. ENGSTROM; CRITICAL CARE VENTILATER
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DATEX-OHMEDA, INC. ENGSTROM; CRITICAL CARE VENTILATER Back to Search Results
Model Number 1505-9000-000
Device Problems Break (1069); Device Tipped Over (2589)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare has been unable to contact the hospital.No resolution is available.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Date received by manufacturer: this mdr malfunction event was previously eligible for the voluntary malfunction summary reporting (vmsr) program.As of 9/16/2019 notification from fda, this product code is no longer eligible for vmsr.According to the notification, ge healthcare must submit individual reports within 30 calendar days of receiving the notification.Therefore, this event is being reported as an individual mdr report due 10/16/2019.
 
Event Description
The hospital reported the caster wheel broke off the unit during patient use, resulting in the unit tipping.There was no report of patient injury.
 
Manufacturer Narrative
Additional information was received that the hospital engineer replaced the caster to resolve the reported issue.H3 other text : additional information was received that the hospital engineer replaced the caster to resolve the reported issue.
 
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Brand Name
ENGSTROM
Type of Device
CRITICAL CARE VENTILATER
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key9132324
MDR Text Key200697412
Report Number2112667-2019-00744
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K041775
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1505-9000-000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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