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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC. TOTALCARE BED; BED, FLOTATION THERAPY, POWERED
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HILL-ROM, INC. TOTALCARE BED; BED, FLOTATION THERAPY, POWERED Back to Search Results
Model Number P1900N006976
Device Problems Unintended Head Motion (1284); Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Date 05/30/2016
Event Type  malfunction  
Event Description
Pt bed - head of the bed continually lowers itself.Documented occurrences: 23:00-02:54 3 times, 02:54-04:00 1 time, 04:00-05:12 1 time, 05:12-05:57 1 time.Realistically, once per hour the bed was below 30% and had to be re-elevated to meet icu protocol.Bed alarm was on, thus alarming each time it occurred.
 
Event Description
Pt bed - head of the bed continually lowers itself.Documented occurrences: 23:00-02:54 3 times, 02:54-04:00 1 time, 04:00-05:12 1 time, 05:12-05:57 1 time.Realistically, once per hour the bed was below 30% and had to be re-elevated to meet icu protocol.Bed alarm was on, thus alarming each time it occurred.
 
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Brand Name
TOTALCARE BED
Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
HILL-ROM, INC.
1069 state route 46 east
batesville IN 47006
MDR Report Key5784854
MDR Text Key49246198
Report Number5784854
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 06/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberP1900N006976
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2016
Event Location Hospital
Date Report to Manufacturer06/03/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/12/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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