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 2020-03-10 for STD STRETCHER FRAME P8005H000146 manufactured by Hill-rom Mexico.
[186869907]
The hillrom technician found the head brake/steer casters needed to be replaced. Per the hillrom service manual the bed should be subject to an effective maintenance program. An annual service of the bed is advised in order to maintain its characteristics and performance. Brake casters should be checked for cuts, wear and quality of tread, etc. And replaced when necessary. Apply the brake and make sure the stretcher does not move. If there is movement, look at the brake components for wear. Apply the steer, and make sure the stretcher steers correctly. Look at the steer components for wear. Put the stretcher in neutral. Make sure all four casters rotate and roll freely. Adjust or replace components if necessary. A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in october 2019. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the head brake/steer casters to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[186869908]
Hillrom received a report from a hillrom technician stating the stretcher's brakes were not holding. The stretcher was located in storage 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 | 3006697241-2020-00014 |
| MDR Report Key | 9812444 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2014-05-22 |
| Date Added to Maude | 2020-03-10 |
| 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 | LORI DAULTON |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STD STRETCHER FRAME |
| Generic Name | WHEELED STRETCHER |
| Product Code | FPO |
| Date Received | 2020-03-10 |
| Model Number | P8005H000146 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM MEXICO |
| Manufacturer Address | AVE.DEL TELEFONO NO. 200 COL. HUINALA APODACA, NUEVO LEON 66640 MX 66640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |