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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE ENGSTROM; VENTILATOR
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GE HEALTHCARE ENGSTROM; VENTILATOR Back to Search Results
Device Problems Break (1069); Component Falling (1105)
Patient Problem Injury (2348)
Event Date 04/12/2014
Event Type  malfunction  
Event Description
The device was not on a patient at the time.The respiratory therapist was getting a ventilator ready to set up for a patient the following day.She rolled it out of the clean utility room approximately 3 feet when a wheel snapped off.The ventilator fell over as the therapist attempted to stop it from falling and injured her back.
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manufacturer response for ventilator, engstrom (per site reporter).
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unknown at this time.The hospital's biomedical department has been repairing the wheels.
 
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Brand Name
ENGSTROM
Type of Device
VENTILATOR
Manufacturer (Section D)
GE HEALTHCARE
9900 w. innovation drive
rp2138
wauwatosa WI 53226
MDR Report Key3814853
MDR Text Key4397992
Report Number3814853
Device Sequence Number1
Product Code BSZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/05/2014
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer05/16/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
THE DEVICE WAS NOT ON A PATIENT AT THE TIME. THE; SHE ROLLED IT OUT OF THE CLEAN UTILITY ROOM; RESPIRATORY THERAPIST WAS GETTING A VENTILATOR; VENTILATOR FELL OVER AS THE THERAPIST ATTEMPTED TO; APPROXIMATELY 3 FEET WHEN A WHEEL SNAPPED OFF. THE; READY TO SET UP FOR A PATIENT THE FOLLOWING DAY.; STOP IT FROM FALLING AND INJURED HER BACK.
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