MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-08-20 for ADVANTA FRAME 1600 manufactured by Hill-rom Batesville.
[23659337]
Hill-rom technical support suggested to check the side rail switches. Per the hill-rom service manual the advanta bed requires an effective maintenance program. Preventative maintenance will minimize downtime due to excessive wear. Run the head section to the full upper and lower limits to ensure proper function of the limit switches. 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. Three attempts have been made regarding a resolution to this contact line, with no response. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[23659338]
Hill-rom received a report from the account stating the head section would self-run when the bed is plugged in. The bed was located in a regular patient care room 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 | 1824206-2015-00822 |
| MDR Report Key | 5017795 |
| Report Source | USER FACILITY |
| Date Received | 2015-08-20 |
| Date of Report | 2015-07-24 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-07-24 |
| Device Manufacturer Date | 2003-01-08 |
| Date Added to Maude | 2015-08-20 |
| 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 | TONY WERNER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTA FRAME |
| Generic Name | A/C POWERED ADJUSTABLE HOSPITAL BED |
| Product Code | FNK |
| Date Received | 2015-08-20 |
| Model Number | 1600 |
| 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 | 2015-08-20 |