MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for AFFINITY 4 BED FRAME P3700D000013 manufactured by Hill-rom Batesville.
[144687042]
The hill-rom technical support representative performed troubleshooting over the phone with the account. The technical support representative recommended replacing all four casters and the brake detent. Per the hill-rom service manual the affinity? Three birthing bed and affinity? Four birthing beds require an effective maintenance program. We recommend that you perform semiannual preventive maintenance. Check the tires for cuts, wear, tread life, etc. Apply the brake, and check to ensure that the bed will not move. If the bed moves, inspect it for wear, and adjust if required. Apply the steering pedal and check the steering to ensure proper locking action when activated. 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 account will replace the brake casters and detent to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[144687043]
Hill-rom technical support received a report from the account stating the brakes were not holding. The bed was located in labor and delivery at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2019-00197 |
| MDR Report Key | 8596778 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-04-25 |
| Device Manufacturer Date | 2012-08-29 |
| Date Added to Maude | 2019-05-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMILY MITCHELL |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129310130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AFFINITY 4 BED FRAME |
| Generic Name | TABLE, OBSTETRIC |
| Product Code | KNC |
| Date Received | 2019-05-09 |
| Model Number | P3700D000013 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM BATESVILLE |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |