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

Model Number P3700B000107

Device Problem Unintended Movement (3026)

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

Event Date 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

The hillrom service technician identified that the brakes would set but would not hold.The technician replaced the brake detent mechanism assembly to resolve this issue.The affinity® 4 birthing bed is intended to be used as a birthing bed for women of child bearing 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 affinity iv brake and steer pedals are connected in the center of the base frame by the detent assembly which is used to synchronize the action of the brake/steer functions from either the left or right sides of the bed.When the pedal is pressed down into the brake position, this causes the detent assembly to actuate the brake linkage of all four casters, therefore placing all four casters into brake.When the pedal is pressed down into the steer position, the brake linkage will only actuate the foot left brake, thus leaving the other three casters in a free swivel condition.When the detent is broken the brake and steer functions will not operate properly, thus allowing the brake/steer functionality to be uncontrolled.A core component of the affinity iv braking system is the brake detent assembly.The brake detent assembly for this affinity iv bed is comprised of a plastic injection molded housing, steel detent coupler with pins, steel plunger and a compression spring.Hillrom¿s investigation results indicate the most probable root cause of the malfunction of the detent housing is tensile stress combined with wear from use.Frequent brake/neutral/steer activations during use of the bed may contribute to bed¿s brake system wear.If the brake detent housing malfunctions, the user is immediately aware as the braking system will not engage on the bed.The global complaint rate continues to be low for detent malfunctions for 2021.There have been no reports of injuries or deaths related to this failure mode.Hillrom considers this to be a highly detectable failure mode since as it occurs the user will recognize the brakes are not engaging and remove the bed from service until repaired.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in (b)(6) 2021.It is unknown if the facility performed any other preventative maintenance on this bed.Additionally, per the hillrom's service manual, the affinity® three birthing bed and affinity® four birthing beds require an effective maintenance program.A semiannual preventive maintenance schedule is recommended which includes checking the brakes.The manual instructs: apply the brake, and check to ensure that the bed will not move.If the bed moves, inspect it for wear, and adjust if required.Apply the steering pedal and check the steering to ensure proper locking action when activated.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed brakes were not holding.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).

• 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: 14045094
• MDR Text Key: 291505818
• Report Number: 1824206-2022-00173
• Device Sequence Number: 1
• Product Code: KNC
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3700B000107
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Date Device Manufactured: 02/26/2010
• 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