MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-08-10 for OLYMPUS MH-706 MONITOR TRAY 7284292 manufactured by Keymed (medical & Industrial Equipment), Ltd..
[181929]
The head of medical physics called keymed to report that a 20" tv monitor, complete with its support column, had become detached from an olympus wm-30 mobile workstation when the monitor had struck an overhead theatre light gantry while being moved between departments. Examination showed that all four of the m8 x 55mm screws which should secure the support column to the top tray of the wm-30 had worked loose from the unit, leaving it superficially fixed by only two m3 screws, which were not designed to support the weight of the monitor. The monitor fell down the front of the wm-30, attached only by signal cables at the rear, causing the workstation to topple over. No one suffered serious injury in the incident, but one member of staff sustained a cut to the left arm when staff tried to prevent the monitor from falling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2000-00001 |
| MDR Report Key | 290227 |
| Report Source | 06 |
| Date Received | 2000-08-10 |
| Date of Report | 2000-08-09 |
| Date of Event | 2000-06-07 |
| Date Mfgr Received | 2000-06-07 |
| Device Manufacturer Date | 1999-07-01 |
| Date Added to Maude | 2000-08-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR R GRAY |
| Manufacturer Street | STOCK ROAD |
| Manufacturer City | SOUTHEND-ON-SEA, ESSEX SS2 5QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS2 5QH |
| Manufacturer Phone | 702616333 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | MOBILE ENDOSCOPY WORKSTATION |
| Product Code | KHX |
| Date Received | 2000-08-10 |
| Returned To Mfg | 2000-06-14 |
| Model Number | MH-706 MONITOR TRAY |
| Catalog Number | 7284292 |
| Lot Number | 113644 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 280884 |
| Manufacturer | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
| Manufacturer Address | STOCK RD. SOUTHEND-ON-SEA, ESSEX UK SS2 5QH |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | MOBILE ENDOSCOPY WORKSTATION |
| Baseline Model No | MH-706 MONITOR |
| Baseline Catalog No | 7284292 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-08-10 |