AFFINITY 4 BIRTHING BED 3.70000000000000e+235

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-14 for AFFINITY 4 BIRTHING BED 3.70000000000000e+235 manufactured by Hill-rom, Inc.

Event Text Entries

[80068097]
Patient Sequence No: 1, Text Type: N, H10

[80068098] 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 We did several onsite demonstrations to show how each of their suggested outdated draping techniques would not work.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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6713606
• MDR Report Key: 6713606
• Date Received: 2017-07-14
• Date of Report: 2017-07-11
• Date of Event: 2017-05-01
• Report Date: 2017-07-11
• Date Reported to FDA: 2017-07-11
• Date Reported to Mfgr: 2017-07-11
• Date Added to Maude: 2017-07-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: AFFINITY 4 BIRTHING BED
• Generic Name: TABLE, OBSTETRIC (AND ACCESSORIES)
• Product Code: KNC
• Date Received: 2017-07-14
• Model Number: 3.70000000000000e+235
• Operator: NURSE
• Device Availability: Y
• Device Age: 4 YR
• Device Eval'ed by Mfgr: R
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: HILL-ROM, INC
• Manufacturer Address: 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006

Device Sequence Number: 1

• Brand Name: AFFINITY 4 BIRTHING BED
• Generic Name: TABLE, OBSTETRIC (AND ACCESSORIES)
• Product Code: HDD
• Date Received: 2017-07-14
• Model Number: 3700E000232
• Operator: NURSE
• Device Availability: Y
• Device Age: 4 YR
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HILL-ROM, INC
• Manufacturer Address: 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-07-14