MAUDE Adverse Event Report: HILL-ROM BATESVILLE P3700C CONFIGURATION AFFINITY; BIRTHING BED

Model Number P3700C

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

The account found the side rail power control board needed 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.It is unknown if the facility performs preventative maintenance on their beds.The account replaced the side rail power control board to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the head would raise itself 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 complaint #(b)(4).

• Brand Name: P3700C CONFIGURATION AFFINITY
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 6407095
• MDR Text Key: 70306023
• Report Number: 1824206-2017-00123
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 02/22/2017

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: P3700C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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