XL BARIATRIC BED P610B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for XL BARIATRIC BED P610B manufactured by Hill-rom Batesville.

Event Text Entries

[101534651] The hill-rom technician found the brake casters needed to be replaced. Per the hill-rom service manual it is necessary for the excel care? Bariatric bed to have an effective maintenance program. We recommend that you do annual preventive maintenance. Preventative maintenance will minimize downtime due to excessive wear. Examine the casters annually for cuts and wear. Repair or replace as necessary. Set the brakes. Make sure the bed does not move. Make sure the steering mechanism operates correctly. Repair or replace the brake and steer mechanism as necessary. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2017. The technician will replace the brake casters once the parts arrive to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[101534652] Hill-rom received a report from the account stating the 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1824206-2018-00098
MDR Report Key7302275
Date Received2018-02-28
Date of Report2018-02-14
Date of Event2018-02-14
Date Mfgr Received2018-02-14
Date Added to Maude2018-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationHOSPITAL SERVICE TECHNICIAN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTONY WERNER
Manufacturer Street1069 STATE ROUTE 46 EAST
Manufacturer CityBATESVILLE IN 47006
Manufacturer CountryUS
Manufacturer Postal47006
Manufacturer Phone8129312359
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameXL BARIATRIC BED
Generic NameBARIATRIC BED
Product CodeOSI
Date Received2018-02-28
Model NumberP610B
OperatorOTHER CAREGIVERS
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM BATESVILLE
Manufacturer Address1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-28

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