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 Number: 3953
• MDR Report Key: 3953
• Date Received: 1992-08-28
• Date of Report: 1992-07-28
• Date of Event: 1992-04-05
• Date Facility Aware: 1992-04-05
• Report Date: 1992-07-28
• Date Reported to Mfgr: 1992-04-10
• Date Added to Maude: 1993-05-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HILL ROM
• Generic Name: OVER BED TABLE
• Product Code: IYZ
• Date Received: 1992-08-28
• Model Number: 631-1
• Catalog Number: NA
• Lot Number: NA
• ID Number: HOSP ASSET #05424
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 3689
• Manufacturer: HILL ROM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-28