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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 P3700C000098
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2023
Event Type  malfunction  
Event Description
Baxter received a report from a baxter technician stating the head of bed moved up by itself.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).
 
Manufacturer Narrative
No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
 
Manufacturer Narrative
The baxter technician found the pcb 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.Check the switches in the side rails to ensure they are functioning correctly.Also check for intermittent operation.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in (b)(6) 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the pcb 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 head of bed moved up by itself.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
esteohania cardenas
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key18025118
MDR Text Key326822826
Report Number1824206-2023-01214
Device Sequence Number1
Product Code KNC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
TABLE, OBST
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,Followup
Report Date 01/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberP3700C000098
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2013
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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