MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-08-15 for PRIMA XTEND CEILING ARM 1364 NA manufactured by Hill-rom Architectural Products, Hill-rom.
[892601]
The power cable for the prima xtends monitor arm had exposed wires due to a cut in the insulation. A spark from the wire was observed by a contractor replacing cabling at the facility. The power cable was replaced to repair the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836145-2008-00004 |
| MDR Report Key | 1120071 |
| Report Source | 00 |
| Date Received | 2008-08-15 |
| Date of Report | 2008-07-16 |
| Date of Event | 2008-07-16 |
| Date Mfgr Received | 2008-07-16 |
| Date Added to Maude | 2009-02-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KRISTEN WILHELM, J32 |
| Manufacturer Street | 1069 STATE ROUTE 46 E |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129347408 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMA XTEND CEILING ARM |
| Generic Name | SUSPENSION ARM |
| Product Code | IYB |
| Date Received | 2008-08-15 |
| Model Number | 1364 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM ARCHITECTURAL PRODUCTS, HILL-ROM |
| Manufacturer Address | WEST PEARL AND WALNUT STREETS BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-15 |