AFFINITY BED 3600D07 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-11-09 for AFFINITY BED 3600D07 * manufactured by Hill-rom, Inc..

Event Text Entries

[174840] Additional info received from the mfr on 12/26/1998: the foot section performed as intended when lock was fully engaged. No discrepancies/ abnormalities were noticed with the device during the visual inspection. During the inspection of the device at the facility (by the mfr technician), a member of the nursing staff suggested that when they or the housekeeper were making the beds and trying to tuck the sheets underneath the footplate, they were constantly hitting the latch. It was stated to the technician that she believed that this could be what was possibly causing them to unlatch. The unit was not returned to the mfr, but was inspected at the user facility. Could not duplicate occurrence when latch was fully engaged and returned to service.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1014914
MDR Report Key	195980
Date Received	1998-11-09
Date of Report	1998-10-14
Date of Event	1998-08-20
Date Added to Maude	1998-11-12
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 Details

Brand Name	AFFINITY BED
Generic Name	BIRTHING BED
Product Code	HHP
Date Received	1998-11-09
Model Number	3600D07
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	190409
Manufacturer	HILL-ROM, INC.
Manufacturer Address	1069 STATE ROUTE 46 EAST BATESVILLE IN 470069167 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-11-09