AFFINITY 2 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-09 for AFFINITY 2 * manufactured by Hill-rom Co, Inc..

Event Text Entries

[162225] 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.
Patient Sequence No: 1, Text Type: D, B5

[180190] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1018104
• MDR Report Key: 261829
• Date Received: 2000-02-09
• Date of Report: 2000-02-04
• Date Added to Maude: 2000-02-14
• Event Key: 0
• Report Source Code: Voluntary 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: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: AFFINITY 2
• Generic Name: BIRTHING BED
• Product Code: HDD
• Date Received: 2000-02-09
• Model Number: AFFINITY 2
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 253579
• Manufacturer: HILL-ROM CO, INC.
• Manufacturer Address: WEST PEARL & WALNUT STS. BATESVILLE IN 47006 US

Device Sequence Number: 2

• Brand Name: AFFINITY 2
• Generic Name: BIRTHING BED
• Product Code: HOD
• Date Received: 2000-02-09
• Model Number: AFFINITY 2
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 253716
• Manufacturer: HILL-ROM CO., INC.
• Manufacturer Address: WEST PEARL & WALNUT STS. BATESVILLE IN 47006 US

Device Sequence Number: 3

• Brand Name: AFFINITY 2
• Generic Name: BIRTHING BED
• Product Code: HOD
• Date Received: 2000-02-09
• Model Number: AFFINITY 2
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 253717
• Manufacturer: HILL-ROM CO., INC.
• Manufacturer Address: WEST PEARL & WALNUT STS. BATESVILLE IN 47006 US

Device Sequence Number: 4

• Brand Name: AFFINITY 2
• Generic Name: BIRTHING BED
• Product Code: HOD
• Date Received: 2000-02-09
• Model Number: AFFINITY 2
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 253719
• Manufacturer: HILL-ROM CO., INC.
• Manufacturer Address: WEST PEARL & WALNUT STS. BATESVILLE IN 47006 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-02-09