MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for AFFINITY 4 BED FRAME P3700D000003 manufactured by Hill-rom Batesville.
[138557741]
The hill-rom technician found the detent mechanism needed to be replaced. 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 showed hill-rom performed preventative maintenance on this bed in (b)(6) 2014. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the detent mechanism to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[138557742]
Hill-rom received a report from the hill-rom service technician stating the brakes were not holding properly. The bed was located on the 2nd floor 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 | 1824206-2019-00098 |
| MDR Report Key | 8405104 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2011-12-04 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| 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 | 2019-03-08 |
| Model Number | P3700D000003 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-08 |