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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE AFFINITY 4 BED FRAME; TABLE, OBSTETRIC (AND ACCESSORIES)

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HILL-ROM BATESVILLE AFFINITY 4 BED FRAME; TABLE, OBSTETRIC (AND ACCESSORIES) Back to Search Results
Model Number P3700E000001
Device Problem Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2023
Event Type  malfunction  
Manufacturer Narrative
The baxter technician found the bracket assembly needed to be replaced.The affinity® 4 birthing bed requires an effective maintenance program.We recommend that you do annual preventive maintenance (pm) for joint commission certification.Pm not only meets joint commission requirements but can help make sure of a long, operative life for the affinity® 4 birthing bed.Two effective ways to reduce downtime and make sure the patient remains comfortable are to keep accurate records and maintain the affinity® 4 birthing bed.Test the cpr release for proper operation and reset of the head drive system.When the cpr release is pulled, the bed should lower from any position into a flat position within 7 seconds with at least 50 lb (23 kg) of weight on the head section.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the bracket assembly to resolve the reported event.Based on this information, no further action is required.
 
Event Description
Baxter received a report from a baxter technician stating the bed cpr was inoperative.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).
 
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Brand Name
AFFINITY 4 BED FRAME
Type of Device
TABLE, OBSTETRIC (AND ACCESSORIES)
Manufacturer (Section D)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
Manufacturer Contact
estephania cardenas
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key18183250
MDR Text Key328810512
Report Number1824206-2023-01292
Device Sequence Number1
Product Code KNC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberP3700E000001
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/24/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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