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

Model Number 3700

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the bed is positioning itself in char position automatically (self-run).The bed was located at the account.T here 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 the self-run due to power control board in the siderail is broken.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 replaced the power control board to resolve the issue.Based on this information, 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 rt 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3929056
• MDR Text Key: 4670726
• Report Number: 1824206-2014-01809
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K915779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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