TC BARIATRIC PLUS W/ AIR P1840RE200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-12-20 for TC BARIATRIC PLUS W/ AIR P1840RE200 manufactured by Hill-rom Batesville.

Event Text Entries

[131012616] The hill-rom technician found that both foot casters needed to be replaced. Per the hill-rom 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) for joint commission certification. Pm not only meets joint commission requirements but can help make sure a long, operative life for the totalcare? Bariatric bed and totalcare? Bariatric plus therapy system. 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 pm search was performed and the records show that the last pm date was (b)(4) 2018 the technician replaced the both foot casters to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[131012617] Hill-rom received a report from a customer 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1824206-2018-00487
MDR Report Key8183834
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2018-12-20
Date of Report2018-12-05
Date of Event2018-12-05
Date Mfgr Received2018-12-05
Device Manufacturer Date2007-03-21
Date Added to Maude2018-12-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHAWN FLANNERY
Manufacturer Street1069 STATE ROUTE 46 EAST
Manufacturer CityBATESVILLE IN 47006
Manufacturer CountryUS
Manufacturer Postal47006
Manufacturer Phone8129313362
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTC BARIATRIC PLUS W/ AIR
Generic NameBARIATRIC BED
Product CodeOSI
Date Received2018-12-20
Model NumberP1840RE200
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 2018-12-20

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