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

Model Number P3700D000001

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technical support representative performed troubleshooting over the phone with the account, determining the brake detent assembly needs to be replaced.Per the hillrom service manual the affinity® three birthing bed and affinity® four birthing beds require an effective maintenance program.We recommend that you perform semiannual preventive maintenance.Check the tires for cuts, wear, tread life, etc.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.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.Hillrom technical support provided the account the part number of the brake detent assembly that needs to be replaced to resolve the issue.The account ordered the part and will repair the bed themselves.Based on this information, no further action is required.

Event Description

Hillrom technical support received a report from the account stating the bed's brakes would set but would pop out of brake mode if the bed was bumped (the 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
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 10734927
• MDR Text Key: 214622778
• Report Number: 1824206-2020-00461
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3700D000001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2013
• 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