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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE BARIATRIC CAPITAL; BED, FLOTATION THERAPY, POWERED

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HILL-ROM BATESVILLE TOTALCARE BARIATRIC CAPITAL; BED, FLOTATION THERAPY, POWERED Back to Search Results
Model Number P1840DCA000038
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
Event Type  malfunction  
Manufacturer Narrative
The hillrom technician found the bed brake alarm did not work.Per the hillrom service manual, the totalcare® bariatric bed and totalcare® bariatric plus therapy system require an effective maintenance program.We recommend that you perform semi-annual preventive maintenance (pm).Pm will minimize downtime due to excessive wear.Unlock the brakes.The system sounds a periodic audible beep, and the brake not set indicator flashes.Make sure the brake not set control is correctly adjusted.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in february 2018.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced recalibrated the pcb, connected all wires correctly, and checked the scale to resolve the issue.Based on this information, no further action is required.
 
Event Description
Hillrom received a report from a hillrom technician stating the bed brake not set alarm did not work.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
 
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Brand Name
TOTALCARE BARIATRIC CAPITAL
Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
Manufacturer Contact
bradley wheeler
1069 state route 46 east
batesville, IN 47006
3128199307
MDR Report Key12844173
MDR Text Key281017426
Report Number1824206-2021-00554
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K122473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberP1840DCA000038
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/27/2021
Initial Date FDA Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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