inforMED
MalfunctionIYZ

HILL ROM

Received Aug 28, 1992 · Event occurred Apr 5, 1992

Report 3953 · MDR key 3953

Device

Generic name

Over Bed Table

Manufacturer

Hill Rom

Model number

631-1

Catalog number

NA

Lot number

NA

Patient

84 YR

Narrative

Description of Event or Problem

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.