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

Model Number P3700E

Device Problems Break (1069); Connection Problem (2900); Device Contamination With Biological Material (2908); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/07/2017

Event Type  malfunction  

Event Description

There is a design flaw in how these hill rom labor and delivery beds are made.There are bellows on the stirrups that are meant to be flexed back and forth.Unfortunately these bellows continually break or become disconnected allowing blood and body fluids to contaminate the inside of the bellows.The hill rom reps were here and feel this is a draping issue, but i don't see how adding drapes to the patient's legs will help prevent fluids to run down and enter where the bed continuously fails.Also the vendor seems to think we are the only hospital system experiencing this issue, which i find hard to believe since each of our three hospitals within the system is seeing this issue.Manufacturer response for hill rom labor and delivery bed, affinity four bed frame (per site reporter).Hill rom representatives were here on site recently, and they do not see this as a design problem, they believe that we are not draping our patients appropriately, which has nothing to do with the way the bellows are failing and falling apart.

• 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: 6713884
• MDR Text Key: 80069167
• Report Number: 6713884
• 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: Other
• Type of Report: Initial
• Report Date: 07/10/2017

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: P3700E
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2017
• 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: NA.