MAUDE Adverse Event Report: HILL-ROM, INC AFFINITY 4 BIRTHING BED; TABLE, OBSTETRIC (AND ACCESSORIES)

Model Number 3.70000000000000e+235

Device Problems Break (1069); Crack (1135); Leak/Splash (1354)

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

Event Date 05/01/2017

Event Type  malfunction  

Event Description

There is a design flaw in how these hill rom affinity 4 beds are made.There is a bellow on the stirrup/foot pedal (both left and right side) that is meant to flex back and forth during labor.Unfortunately these bellows continually crack and break requiring frequent replacement.Hill rom was aware of this issue and stated they have made the bellows with a more pliable material.No notification was made regarding that, including no opportunity to ship back bellows that would crack quickly for bellows of the new material.These bellows also likely become dislodged thereby allowing bodily fluids and blood to contaminate inside the bellows and at the collar.The hill rom reps were here recently and feel that this is a draping issue.We did several onsite demonstrations to show how each of their suggested outdated draping techniques would not work.No additional suggestions were offered at this time.Hill rom said they would regroup and let us know what they come up with.All three hospitals in our system are seeing this issue.Hill rom's technician has mentioned seeing this issue at other hospitals in the area.Manufacturer response for hill rom labor and delivery bed, affinity 4, affinity four (per site reporter).Hill rom sent several representatives to view the beds and the problems recently.They did not see this as a design problem and seemed to be looking for us to be at fault.They mentioned many times they are not seeing this issue everywhere.They emphasized draping which has nothing to do with bellow cracking and fluid leaking in.

• Brand Name: AFFINITY 4 BIRTHING BED
• Type of Device: TABLE, OBSTETRIC (AND ACCESSORIES)
• Manufacturer (Section D): HILL-ROM, INC; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6713606
• MDR Text Key: 80068098
• Report Number: 6713606
• Device Sequence Number: 0
• Product Code: KNC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 3.70000000000000e+235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N/A.