MAUDE Adverse Event Report: HILL-ROM BATESVILLE AFFINITY 4 BED FRAME; BIRTHING BED

Model Number P3700E000340

Device Problems Unintended Head Motion (1284); Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

The distributor technician found the right side rail control are the issue and need to be replaced.Per the hill-rom 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 (pm) along with a quarterly battery check and testing for joint commission on accreditation of healthcare organizations (jcaho).Pm and testing not only meet jcaho requirements but will help ensure a long, operative life for the bed.Pm will minimize downtime due to excessive wear.Check the switches in the side rails to ensure they are functioning correctly.Also check for intermittent operation.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician will replace the right side rail controls to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the distributor technician stating the head section would self run up.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: AFFINITY 4 BED FRAME
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 6661240
• MDR Text Key: 78369905
• Report Number: 1824206-2017-00257
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K915779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: P3700E000340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1