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 04/16/2014

Event Type  malfunction  

Event Description

Customer reported that the plastic elbow cover detached from a modutec plg pendant and fell during cleaning.The nylon screws used to fix the cover on pendant were found broken.No patient was involved.(b)(4).

Manufacturer Narrative

A maquet field service technician (fst) visited the hospital and evaluated the device.The cover that fell and the nylon screws used to secure it were discarded by the customer so no parts could be returned for evaluation.The fst observed a c-arm and other medical devices in close proximity to ceiling pendant.While collision between these devices and the subject device is a possible factor in the described failure, we have not been able to confirm this.Maquet reviewed the design of the plg elbow cover, and mechanical evaluation testing was performed.No issues were found.The maquet fst replaced the cover and secure it to the pendant with the nylon screws.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: MAQUET CEILING SUPPLY UNITS
• Type of Device: CEILING SUPPLY UNITS
• Manufacturer (Section D): MAQUET SUZHOU CO. LTD; suzhou 0000 ; CH 0000
• Manufacturer (Section G): MAQUET SUZHOU CO. LTD; no.158 fang zhou road suzhou industrial park; suzhou 0000 ; CN 0000
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470-0000 ; 9737097753
• MDR Report Key: 3898965
• MDR Text Key: 4647155
• Report Number: 3007417753-2014-00002
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/16/2014,04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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