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

Model Number P3700C000010

Device Problem Device Tipped Over (2589)

Patient Problem Bruise/Contusion (1754)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

It was reported by a customer that the affinity 4 birthing bed tilted during a delivery and the caregiver was injured.Details of the injury and medical intervention, if any, were not reported.There was no report of injury to the patient.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

It was reported by a customer that the affinity 4 birthing bed tilted during a delivery and the caregiver was injured.Details of the injury and medical intervention, if any, were not reported.There was no report of injury to the patient.The customer¿s senior engineer reported the following information to the baxter service technician who inspected the bed.The caregiver sustained some bruising on their lap/knee area from the bed tipping forward.No medical intervention was reported.No injury to the patient or fetus/newborn infant was reported.The affinity 4 birthing bed is intended to be used as a birthing bed for women of childbearing age in an ldr (labor, delivery, recovery) or ldrp (labor, delivery, recovery, postpartum) setting within the acute care labor and delivery market.It is not intended for use as a general hospital bed.The baxter service technician inspected the bed and the retaining strap for the head weldment was missing causing the bed frame to tip forward.No preventative maintenance (pm) dates were noted on the bed and baxter is not responsible for the pm process at this facility.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.A contusion (bruise) is an injury to tissue with skin discoloration and without breakage of skin.Most bruises heal without treatment, but cold compresses may reduce swelling, discoloration, and pain.There was no report of medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes a serious injury did not occur.The cause of the event was likely related to the bed frame tipping due to a missing retaining strap for the head weldment.If the reported problem were to recur, it would be likely to cause or contribute to a death or serious injury.

• 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: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18050256
• MDR Text Key: 327099359
• Report Number: 1824206-2023-01221
• Device Sequence Number: 1
• Product Code: KNC
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3700C000010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2011
• 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