VERSACARE FRAME 3200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-20 for VERSACARE FRAME 3200 manufactured by Hill-rom Batesville.

Event Text Entries

[23659207] The hill-rom technician found the communication cable inoperable. Per the hill-rom user manual, warning: a communication cable must be used for beds that have nurse call. Failure to do so could cause patient injury. For beds that have nurse call systems, a communication cable must be connected between the bed and facility communication system. A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed. It is unknown if the facility performs preventative maintenance on their beds. The technician replaced the communication cable to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[23659208] Hill-rom received a report from a hill-rom technician stating the nurse call not working. 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 Number1824206-2015-00826
MDR Report Key5018019
Report SourceCOMPANY REPRESENTATIVE
Date Received2015-08-20
Date of Report2015-07-28
Date of Event2015-07-28
Date Mfgr Received2015-07-28
Device Manufacturer Date2012-11-20
Date Added to Maude2015-08-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOHN CUMMINGS
Manufacturer Street1069 STATE ROUTE 46 EAST
Manufacturer CityBATESVILLE IN 47006
Manufacturer CountryUS
Manufacturer Postal47006
Manufacturer Phone8129312869
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERSACARE FRAME
Generic NameA/C POWERED ADJUSTABLE HOSPITAL BED
Product CodeFNK
Date Received2015-08-20
Model Number3200
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 2015-08-20

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