MAUDE Adverse Event Report: MAQUET SAS BLUE 30

Model Number BLUE30 S

Device Problems Material Disintegration (1177); Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

The customer reported to maquet that a bulb exploded and caused glass splinters falling on the operating area during an ambulatory surgery.No injuries were reported.(b)(4).

Manufacturer Narrative

For a similar event, maquet (b)(4) contacted the supplier of the halogen bulbs for assistance.The supplier reported they test 100% of the bulbs in a vacuum oven in order to reduce risks of bursting.Continued use of lamp beyond stated bulb life, and overvoltage or a weakness of the bulb's glass caused by contaminate (e.G.Fingerprint) can lead to the type of failure reported.The device has been repaired by the hospital.

• Brand Name: BLUE 30
• Manufacturer (Section D): MAQUET SAS; orleans ; FR
• Manufacturer Contact: parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 45074 ; 9737097753
• MDR Report Key: 4177054
• MDR Text Key: 5101702
• Report Number: 9710055-2014-00084
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K954169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BLUE30 S
• Device Catalogue Number: 55002093S
• Other Device ID Number: 56077460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1