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 11/25/2014

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 labor and delivery at the account.There was no patient/user injury reported.

Manufacturer Narrative

Hill-rom technical support suggested isolating each side rail and pc board.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.No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information 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: 4379078
• MDR Text Key: 5119688
• Report Number: 1824206-2014-02861
• 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: Other
• Type of Report: Initial
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• 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: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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