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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MODULAR SERVICES COMPANY STRATUS; STRATUS BOOM
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MODULAR SERVICES COMPANY STRATUS; STRATUS BOOM Back to Search Results
Device Problems Component Falling (1105); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/26/2017
Event Type  malfunction  
Event Description
Reportedly, the boom, which is attached to the ceiling in the patient room, was being repositioned by the nurse in order to provide more room for the parent to feed the patient.The patient was located below the boom.As the boom was moved around, a piece of the boom, which was described as c-shaped, reportedly fell off and the nurse caught the piece before it hit the patient.No patient harm reported.
 
Event Description
Reportedly, the boom, which is attached to the ceiling in the patient room, was being repositioned by the nurse in order to provide more room for the parent to feed the patient.The patient was located below the boom.As the boom was moved around, a piece of the boom, which was described as c-shaped, reportedly fell off and the nurse caught the piece before it hit the patient.No patient harm reported.
 
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Brand Name
STRATUS
Type of Device
STRATUS BOOM
Manufacturer (Section D)
MODULAR SERVICES COMPANY
500 e. britton rd.
oklahoma city OK 73114
MDR Report Key6449329
MDR Text Key79648731
Report Number6449329
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2017
Is this a Product Problem Report? Yes
Device Operator Nurse
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2017
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer02/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
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