MAUDE Adverse Event Report: THE BINDING SITE GROUP LTD. OPTILITE ANALYSER

Catalog Number IE700

Device Problem Insufficient Information (3190)

Patient Problem Bruise/Contusion (1754)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

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).

Manufacturer Narrative

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.

• Brand Name: OPTILITE ANALYSER
• Manufacturer (Section D): THE BINDING SITE GROUP LTD.; 8 calthorpe rd.; edgbaston, birmingham B15 1QT; UK B15 1QT
• Manufacturer Contact: kirk buller ; 8 calthorpe rd.; edgbaston, birmingham B15 1-QT ; UK B15 1QT ; 214569500
• MDR Report Key: 4792538
• MDR Text Key: 5852711
• Report Number: 9614373-2015-00001
• Device Sequence Number: 1
• Product Code: CEF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: IE700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2012
• Patient Sequence Number: 1