• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HILL-ROM BATESVILLE TOTALCARE BARIATRIC CAPITAL; BED, FLOTATION THERAPY, POWERED Back to Search Results
Model Number P1840DCA000010
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2023
Event Type  malfunction  
Manufacturer Narrative
The hillrom technician found the pcb needed to be replaced.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 july 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the pcb to resolve the reported event.Based on this information, no further action is required.
 
Event Description
Hillrom received a report from a hillrom technician stating the bed had no audible brake not set alarm.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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
brad wheeler
1069 state route 46 east
batesville, IN 47006
3128199307
MDR Report Key16250366
MDR Text Key309297145
Report Number1824206-2023-00048
Device Sequence Number1
Product Code IOQ
UDI-Device Identifier00887761000865
UDI-Public010088776100086511180206
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
Report Date 01/26/2023
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 NumberP1840DCA000010
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/20/2023
Initial Date FDA Received01/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-