RC1000 RC1000BED

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 2019-04-12 for RC1000 RC1000BED manufactured by Camtec.

Event Text Entries

[141772882] .
Patient Sequence No: 1, Text Type: N, H10


[141772883] It was reported to the manufacturer by the end user, per the end user, "patient fell between side rails and hit her head". Numerous requests to this facility have been made to receive additional information and details related to this alleged incident report with no response from the facility. Complaint# (b)(4) and ra# (b)(4) were entered into our system to have the bed returned to joerns for investigation. As of this writing, the bed have not been returned.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009402404-2019-00021
MDR Report Key8509506
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-04-12
Date of Report2019-04-12
Date of Event2019-03-22
Date Mfgr Received2019-03-25
Date Added to Maude2019-04-12
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 ContactFELICIA BANKS
Manufacturer Street2100 DESIGN ROAD
Manufacturer CityALINGTON TX 76014
Manufacturer CountryUS
Manufacturer Postal76014
Manufacturer Phone8008260270
Manufacturer G1CAMTEC
Manufacturer Street1959 CHURCH CREEK RD
Manufacturer CityCAMBRIDGE MD 21613
Manufacturer CountryUS
Manufacturer Postal Code21613
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRC1000
Generic NameBARIATRIC PATIENT BED
Product CodeOSI
Date Received2019-04-12
Model NumberRC1000BED
Catalog NumberRC1000BED
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCAMTEC
Manufacturer Address1959 CHURCH CREEK RD CAMBRIDGE MD 21613 US 21613


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-12

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