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

Model Number 3700

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2015

Event Type  malfunction  

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 maintenance shop 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

Hill-rom technical support suggested isolating the left side rail.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 unk if the facility performs preventative maintenance on their beds.No further info is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant info is identified following completion of the investigation, the additional relevant info will be submitted in a supplemental report.

• Brand Name: AFFINITY 4 BED
• Type of Device: BIRTHING BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4731058
• MDR Text Key: 5744277
• Report Number: 1824206-2015-00521
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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