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

Model Number P3700E000016

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Event Description

Baxter received a report from a baxter technician stating the head section goes back up after lowering due to right side caregiver board.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

The baxter technician found the right caregiver board 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 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 right caregiver board to resolve the reported event.Based on this information, no further action is required.

• 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: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 18241443
• MDR Text Key: 329405833
• Report Number: 1824206-2023-01343
• Device Sequence Number: 1
• Product Code: KNC
• UDI-Device Identifier: 00887761000896
• UDI-Public: 010088776100089611180815
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3700E000016
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1