MAUDE Adverse Event Report: HILL-ROM, INC. AFFINITY 4 BED; BIRTHING BED

Model Number 3700

Device Problem Device Alarm System (1012)

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

Event Date 06/30/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the nurse call was inoperative.The bed was located at the account.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom technician found a bent pin on the communication cable.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.Check the switch 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 unk if the facility performs preventative maintenance on their beds.The technician repaired the bent pin to resolve the issue.Based on this info, no further action is required.

• Brand Name: AFFINITY 4 BED
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4950333
• MDR Text Key: 22152173
• Report Number: 1824206-2015-00745
• Device Sequence Number: 1
• Product Code: HDD
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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