CLINITRON RITEHITE C-8 ASSY P0800010019

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for CLINITRON RITEHITE C-8 ASSY P0800010019 manufactured by Hill-rom Batesville.

Event Text Entries

[128608670] The hill-rom technician found the patient hand pendant needed to be replaced. Per the hill-rom user manual: powered bed mechanisms can cause serious injury. Operate the bed only with persons clear of moving bed surfaces. If you are trying to access a hydraulic function from the control panel or pendant and the unit is not operating properly, the following message may appear: head position sensors not calibrated. Notify hill-rom a search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in september 2018. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the hand pendant to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[128608671] Hill-rom received a report from the account stating the bed head function is lowering on its own. The bed was located in room 1021 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 Number1824206-2018-00448
MDR Report Key8107547
Date Received2018-11-27
Date of Report2018-11-13
Date of Event2018-11-13
Date Mfgr Received2018-11-13
Device Manufacturer Date2013-11-04
Date Added to Maude2018-11-27
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 Report0

Device Details

Brand NameCLINITRON RITEHITE C-8 ASSY
Generic NameBED, AIR FLUIDIZED
Product CodeINX
Date Received2018-11-27
Model NumberP0800010019
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 2018-11-27

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