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

Model Number P3700D000063

Device Problem Self-Activation or Keying (1557)

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

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the left hand side rail needed to have the contacts cleaned.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 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 cleaned the left hand side rail contacts and the issue was resolved.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the head section would self-run when the bed is plugged in.The bed was located in the labor ward 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: 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: 5265339
• MDR Text Key: 32809724
• Report Number: 0001824206-2015-01059
• Device Sequence Number: 1
• Product Code: KNC
• Combination Product (y/n): N
• 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: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: P3700D000063
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1