MAUDE Adverse Event Report: MAQUET SUZHOU CO. LTD MAQUET; CEILING SUPPLY UNITS

Model Number MODUTEC

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2015

Event Type  No Answer Provided  

Event Description

The customer reported that sparks came out of an electrical outlet located on a ceiling supplier unit.No patient was involved.(b)(4).

Manufacturer Narrative

A maquet fse (field service engineer) visited this hospital and evaluated this device.It was confirmed that the electrical outlet on the boom was observed to be emitting smoke and sparks, and a power cord for a light source was plugged into this outlet at the time during a surgical case.A part of surface of the power cord was melted, and one of the pins was broken off from the power cord plug.No patient was involved.Fse had used a new electrical outlet to replace the damaged one and verified as ok.A review of dhr of same devices did not reveal any non conformities.This device was delivered in 2011, and verified as ok during installation.No other similar cases were reported after putting into use.This is also the first case reported for this kind of failure in a ceiling supply unit based on our complaint database information.Maquet (b)(4) is waiting the defective sample (electrical outlet) back for analysis and further investigation and a follow up report will be submitted.

• Brand Name: MAQUET
• Type of Device: CEILING SUPPLY UNITS
• Manufacturer (Section D): MAQUET SUZHOU CO. LTD; suzhou ; CH
• Manufacturer Contact: helena lu ; no.158 fang zhou road suzhou industrial park; suzhou industrial park; suzhou 21502-4 ; CH 215024 ; 5126936923
• MDR Report Key: 4533987
• MDR Text Key: 5506218
• Report Number: 3007417753-2015-00001
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODUTEC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2015
• Date Device Manufactured: 08/01/2011
• 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