AFFINITY 4 BED FRAME P3700D000010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for AFFINITY 4 BED FRAME P3700D000010 manufactured by Hill-rom Batesville.

Event Text Entries

[138427503] The hill-rom technical support representative performed troubleshooting over the phone with the account, asking the account to isolate the siderail. The account found the right siderail patient control board 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 (pm). Pm will minimize downtime due to excessive wear. Check the switches in the side rails to ensure they are functioning correctly. Also check for intermittent operation. A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed. It is unknown if the facility performs preventative maintenance on their beds. The account will replace the right siderail patient control board to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[138427505] Hill-rom technical support received a report from the account stating the head was raising up by itself. The bed was located in labor and delivery at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1824206-2019-00090
MDR Report Key8395882
Date Received2019-03-06
Date of Report2019-02-22
Date of Event2019-02-22
Date Mfgr Received2019-02-22
Device Manufacturer Date2011-12-13
Date Added to Maude2019-03-06
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 Received2019-03-06
Model NumberP3700D000010
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM BATESVILLE
Manufacturer Address1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-06

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