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

Model Number MODUTEC

Device Problems Component Falling (1105); Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

Customer reported that an end plastic cover fell onto the ground during setup, no patient was involved.The end cover did not fall into a sterile field.(b)(4).

Manufacturer Narrative

A maquet fse (field service engineer) visited the hospital and evaluated the device.The cover that fel of was not broken, but the safety chain was broken off from the middle.The purpose of the safety chain is to prevent the end cover from falling off in case of serious collision with other device obvious evidence of collision could be found on the end cover and the beam of csu.The fse in charge of the initial installation verified that all covers were examined prior to the release of the operating room to the customer; everything was in place and there were no issues at that time.The operating room staff approximately 2 or 3 weeks before it was fell off on (b)(6) based on above, maquet suzhou believes the root issue to be a failure of the or staff to be aware of their surrounding when positioning the other devices and a collision happened.The end cover was not fell off during the first collision, however, a second collision happened on (b)(6) during procedure setup which pull the end cover from broken off of chain.The maquet fst had secured the cover again using spare parts.

• 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 21502-4 ; CH 215024 ; 5126936923
• MDR Report Key: 4208785
• MDR Text Key: 4983798
• Report Number: 3007417753-2014-00004
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• 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: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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