MAUDE Adverse Event Report: MAQUET SAS BLUE 30

Model Number BLUE30SW

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

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

Event Date 12/27/2013

Event Type  malfunction  

Event Description

The customer reported to maquet that a bulb of a blue 30 burst during use, and caused glass splinters to fall onto a neonate patient.No injuries were reported to maquet.(b)(4).

Manufacturer Narrative

The customer has removed the device from service.Maquet has not been informed if or when the device will be repaired.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, an overvoltage of a weakness of the bulb's glass caused by contaminate (e.G.Fingerprint) can lead to the type of failure reported.The blue (b)(4) series operating manual includes the following instruction for users: - 4.1 replacing the light bulb attention: do not touch the glass body of the halogen bulb with bare fingers.- replace the bulb every 600 hours.Should additional information become available, a follow up report will be submitted.Maquet medical systems usa submits this report on behalf of the device manufacturing facility.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: BLUE 30
• Manufacturer (Section D): MAQUET SAS; orleans ; FR
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 4507 4; FR 45074
• Manufacturer Contact: janice pevide ; 45 barbour pond dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3704390
• MDR Text Key: 4234110
• Report Number: 9710055-2014-00007
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K954169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/20/2014,12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BLUE30SW
• Device Catalogue Number: 55002095C
• Other Device ID Number: 56077460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/02/2014
• Device Age: 90 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/30/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2006
• 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