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 P3700E manufactured by Hill-rom, Inc.
[80069166]
Patient Sequence No: 1, Text Type: N, H10
[80069167]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6713884 |
| MDR Report Key | 6713884 |
| Date Received | 2017-07-14 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-07-07 |
| Report Date | 2017-07-10 |
| Date Reported to FDA | 2017-07-10 |
| Date Reported to Mfgr | 2017-07-10 |
| 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 |
| 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 |
| Brand Name | AFFINITY 4 BIRTHING BED |
| Generic Name | TABLE, OBSTETRIC (AND ACCESSORIES) |
| Product Code | KNC |
| Date Received | 2017-07-14 |
| Model Number | P3700E |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 3 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 |
| Brand Name | AFFINITY 4 BIRTHING BED |
| Generic Name | TABLE, OBSTETRIC (AND ACCESSORIES) |
| Product Code | HDD |
| Date Received | 2017-07-14 |
| Model Number | P3700E |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 3 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-14 |