HILL ROM 631-1 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-28 for HILL ROM 631-1 NA manufactured by Hill Rom.

Event Text Entries

[1927] Male patient, 84 years of age, received small cut on lateral side of 4th finger as a result of contact with an over bed table mechanism (table asset #05242). Table slide, hill rom part #624-631 was observed to have sharp end and edges, which apparently inflicted the injury, would was treated with anti-septic and covered, physician was notified and no further treatment or follow-up was recommended. Over-bed table was tagged and sent to maintenance for repair. Maintenance techniciansreported filing several sharp edges off slide mechanisms. Invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: manufacturing. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: invalid data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3953
MDR Report Key3953
Date Received1992-08-28
Date of Report1992-07-28
Date of Event1992-04-05
Date Facility Aware1992-04-05
Report Date1992-07-28
Date Reported to Mfgr1992-04-10
Date Added to Maude1993-05-10
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHILL ROM
Generic NameOVER BED TABLE
Product CodeIYZ
Date Received1992-08-28
Model Number631-1
Catalog NumberNA
Lot NumberNA
ID NumberHOSP ASSET #05424
OperatorOTHER CAREGIVERS
Device AvailabilityY
Implant Flag*
Device Sequence No1
Device Event Key3689
ManufacturerHILL ROM


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-08-28

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