AFFINITY 4 BED FRAME P3700D000011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for AFFINITY 4 BED FRAME P3700D000011 manufactured by Hill-rom Batesville.

Event Text Entries

[144154489] The hill-rom technician found the brake detent needed to be replaced. Per the hill-rom service manual the affinity? Three birthing bed and affinity? Four birthing beds require an effective maintenance program. We recommend that you perform semiannual preventive maintenance. Check the tires for cuts, wear, tread life, etc. Apply the brake, and check to ensure that the bed will not move. If the bed moves, inspect it for wear, and adjust if required. Apply the steering pedal and check the steering to ensure proper locking action when activated. A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in (b)(6) 2019. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the brake detent to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[144154490] Hill-rom received a report from the account stating the brakes were not holding after being set. The bed was located at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1824206-2019-00186
MDR Report Key8577954
Date Received2019-05-03
Date of Report2019-04-23
Date of Event2019-04-23
Date Mfgr Received2019-04-23
Device Manufacturer Date2013-03-11
Date Added to Maude2019-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEMILY MITCHELL
Manufacturer Street1069 STATE ROUTE 46 EAST
Manufacturer CityBATESVILLE IN 47006
Manufacturer CountryUS
Manufacturer Postal47006
Manufacturer Phone8129310130
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAFFINITY 4 BED FRAME
Generic NameTABLE, OBSTETRIC
Product CodeKNC
Date Received2019-05-03
Model NumberP3700D000011
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM BATESVILLE
Manufacturer Address1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-03

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