MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-03 for AFFINITY 4 BED FRAME P3700E000001 manufactured by Hill-rom Batesville.
[180366626]
The hillrom technician found the left and right head casters needed to be replaced. Per the hillrom 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 hillrom maintenance records showed hillrom performed preventative maintenance on this bed in november 2019. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the left and right head casters to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[180366627]
Hillrom received a report from the hillrom service technician stating the brakes were not holding. The bed was located at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824206-2020-00001 |
| MDR Report Key | 9548339 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-24 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2019-12-24 |
| Device Manufacturer Date | 2014-10-22 |
| Date Added to Maude | 2020-01-03 |
| 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 | 3 |
| Brand Name | AFFINITY 4 BED FRAME |
| Generic Name | TABLE, OBSTETRIC |
| Product Code | KNC |
| Date Received | 2020-01-03 |
| Model Number | P3700E000001 |
| 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 | 2020-01-03 |