MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2015-05-11 for OPTILITE ANALYSER IE700 manufactured by The Binding Site Group Ltd..
[5852711]
The cover on the optilite analyser was opened to access the inside of the analyser. The trained member of binding site's staff (applications specialist) thought that the cover was in the fully open position but whilst he was removing reagents, the cover fell on the operator's arm causing bruising. The operator is experienced in using the optilite analyser. The event occured at the manufacturer's own premises in (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13302133]
The analyser is manufactured by thermo fisher (b)(4), who are responsible for design and production. The analyser is badged for binding site, who are responsible for marketing and after-sales service, including vigilance. This event has already been reported by binding site to the nat'l competent authority in the (b)(4) the mhra ((b)(4)). There is currently one optilite analyser in the us, being used for evaluation purposes only, not for medical purposes. Comments on the cause of the event are provided in b5. In the short term, current users will be warned by a field safety notice of the risk of the cover closing when not in the fully open position. In the longer term, the analyser needs to be modified by the original manufacturer (thermo fisher) to either have a stronger gas strut fitted or provided with some type of locking mechanism for when the cover is in the open position.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614373-2015-00001 |
| MDR Report Key | 4792538 |
| Report Source | 00,01,07 |
| Date Received | 2015-05-11 |
| Date of Report | 2015-05-07 |
| Date of Event | 2015-04-10 |
| Date Mfgr Received | 2015-04-10 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2015-06-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRK BULLER |
| Manufacturer Street | 8 CALTHORPE RD. |
| Manufacturer City | EDGBASTON, BIRMINGHAM B15 1QT |
| Manufacturer Country | UK |
| Manufacturer Postal | B15 1QT |
| Manufacturer Phone | 214569500 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTILITE ANALYSER |
| Product Code | CEF |
| Date Received | 2015-05-11 |
| Catalog Number | IE700 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE BINDING SITE GROUP LTD. |
| Manufacturer Address | 8 CALTHORPE RD. EDGBASTON, BIRMINGHAM B151QT UK B15 1QT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-11 |