inforMED
MalfunctionHDD

AFFINITY 2

Received Feb 9, 2000

Report MW1018104 · MDR key 261829

Device

Generic name

Birthing Bed

Manufacturer

Hill-rom Co, Inc.

Model number

AFFINITY 2

Catalog number

*

Lot number

*

Product problems

  • Motor failure
  • Repair
  • Replace

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE LABOR AND DELIVERY DEPT CURRENTLY HAS FOUR HILL-ROM AFFINITY 2 BEDS ON ITS ACCOUNT. ON NUMEROUS OCCASIONS COMPLAINTS HAVE BEEN PRESENTED TO MEDICAL MAINTENANCE ABOUT A HEIGHT ADJUSTMENT PROBLEM. THE NATURE OF THE PROBLEM WAS THAT ONCE THE BED WAS RAISED, IT WOULDN'T LOWER OR WOULD LOWER ABNORMALLY SLOWLY. RPTR CONTACTED HILL-ROM AND THEY STATED THEY HAD RECEIVED SEVERAL SIMILAR COMPLAINTS ABOUT THIS MODEL. THEIR ENGINEERS HAVE SOLVED THE PROBLEM BY REPLACING THE HI-LOW MOTOR ASSEMBLY WITH PART NUMBER 46223-01. TECH SVC AT HILL-ROM SEEMED HESITANT ABOUT RELEASING INFO ABOUT THIS REPLACEMENT PART. HILL-ROM DID SEND REPLACEMENT ASSEMBLIES AT NO CHARGE FOR ALL AFFINITY-2 BEDS. SINCE THEY WERE INSTALLED THERE HAVE NOT BEEN ANY COMPLAINTS.

Description of Event or Problem

ADD'L INFO REC'D FROM MFR 4/10/00: FAILURE MODE: A. HI/LOW DRIVE STICKING AT THE FULL HEIGHT LOCATION. CONCLUSIONS: A. THE HI/LOW DRIVE STICKING ISSUE OCCURS WHEN THE MOTOR STARTING TORQUE IS UNABLE TO OVERCOME THE DRIVE BRAKING TORQUE. B. THE HI/LOW DRIVE STICKING COULD ONLY BE REPRODUCED IN LESS THAN 50% OF THE DRIVES RETURNED FROM THE FACILITIES FOR EVALUATION. C. THE HI/LOW DRIVE STICKING ISSUE HAS NEVER BEEN DUPLICATED IN THE HILL-ROM TEST LAB WITH A NEW BED AND DRIVE, DESPITE RUNNING MULTIPLE HILL-ROM LIFE CYCLE TESTS. DEVICE NOT RETURNED TO MFR, AND HILL-ROM DID NOT RECEIVE ANY REPORT OF A PRODUCT PROBLEM FROM THIS FACILITY UNTIL 3/29/00. ACTION TAKEN: HILL-ROM SENT 4 REPLACEMENT MOTORS, WHICH WERE REPLACED BY A HILL-ROM TECH. THE SUBJECT UNITS WERE 5 YEARS IN AGE. NO DESIGN CHANGES OR MODIFICATIONS HAD BEEN MADE THAT MAY BE RELATED TO THE EVENT.