MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-08 for EPICARE COLUMN 680 manufactured by Hill-rom Architecural Products / Hill-rom Co. Inc.
[17472289]
Alleged the retractable ceiling column drifts down unexpectedly. On (b)(6), an or employee was hit on the head when the ceiling column drifted down. The employee had a headache, went to er, is reported to have a concussion and was sent home for the day. The employee is working but still claims to have an ongoing headache. The facility indicated the drift has been happening for sometime.
Patient Sequence No: 1, Text Type: D, B5
[17637815]
The technician inspected the column and could not duplicate the alleged malfunction. The technician did find small air leaks between the control hoses and press lock fittings. The hoses were re-fitted to the press lock fittings to stop the leaks. The account declined to provide any additional information regarding the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836145-2009-00003 |
| MDR Report Key | 1506623 |
| Report Source | 05 |
| Date Received | 2009-10-08 |
| Date of Report | 2009-09-09 |
| Date of Event | 2009-09-08 |
| Date Mfgr Received | 2009-09-09 |
| Date Added to Maude | 2010-07-13 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK VORNHEDER |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129347163 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICARE COLUMN |
| Generic Name | CEILING COLUMN |
| Product Code | IYB |
| Date Received | 2009-10-08 |
| Model Number | 680 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM ARCHITECURAL PRODUCTS / HILL-ROM CO. INC |
| Manufacturer Address | WEST PEARL & WALNUT STS BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-08 |