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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE TC BARIATRIC PLUS W/AIR & PULM; BED, FLOTATION THERAPY, POWERED
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HILL-ROM BATESVILLE TC BARIATRIC PLUS W/AIR & PULM; BED, FLOTATION THERAPY, POWERED Back to Search Results
Model Number P1840RE300
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2023
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Baxter received a report from a baxter technician stating the bed brakes were not holding.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).
 
Manufacturer Narrative
The baxter technician found the device was scrapped and the root cause could not be identified.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.Inspect the casters for proper mounting, excessive wear, or tread damage.Replace as needed.Verify proper operation of the brake system.Adjust as necessary.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician found the device was scrapped and the root cause could not be identified.Based on this information, no further action is required.
 
Event Description
Baxter received a report from a baxter technician stating the bed brakes were not holding.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
TC BARIATRIC PLUS W/AIR & PULM
Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
Manufacturer Contact
brad wheeler
1069 state route 46 east
batesville, IN 47006
3128199307
MDR Report Key18291084
MDR Text Key330826038
Report Number1824206-2023-01365
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 02/06/2024
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 NumberP1840RE300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/12/2023
Initial Date FDA Received12/08/2023
Supplement Dates Manufacturer Received11/12/2023
Supplement Dates FDA Received02/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2014
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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