MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-24 for PROCEDURAL STRETCHER FRAME P8005G000250 manufactured by Hill-rom Mexico.
[186868383]
The hillrom technical support representative performed troubleshooting over the phone with the account, asking the account to adjust the caster brake and brake/steer pedal. 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 did not show hillrom performed any preventative maintenance on this bed. It is unknown if the facility performs preventative maintenance on their beds. Hillrom technical support contacted the account two additional times trying to obtain the resolution for this alleged issue. No response has been received from the account. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[186868384]
Hillrom technical support received a report from the account stating the stretcher's brakes were not holding. The bed was located in the er 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 | 3006697241-2020-00008 |
| MDR Report Key | 9745380 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2020-02-24 |
| 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 | PROCEDURAL STRETCHER FRAME |
| Generic Name | WHEELED STRETCHER |
| Product Code | FPO |
| Date Received | 2020-02-24 |
| Model Number | P8005G000250 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-24 |