MAUDE Adverse Event Report: MAQUET SUZHOU CO. LTD MAQUET

Model Number MODUTEC

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

It was reported to maquet (b)(4) that a plastic, axis #2 motor cover detached from a modutec power pendant and fell onto a nurse.No injury or other adverse consequences occurred.No patient was involved in this incident.(b)(4).

Manufacturer Narrative

A maquet (b)(4) fse (field service engineer) visited the hospital and evaluated the device.He found the fallen cover had no damage but the three nylon screws used to secure the cover to the device had broken.The fse in charge of the initial installation verified that all covers and screws 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.A review of the design of the cover was made, and mechanical evaluation testing was performed.No issues were found.During the investigation maquet observed a c-arm and other medical devices in close proximity to ceiling pendant, maquet believes the rot issue to be a failure of the operating room staff to be aware of their surrounding when positioning the other devices, and suspects one of these devices collided with the pendant, breaking the fastening screws.The fse replaced the screws to secure the cover during the visit and maquet has advised the customer to avoid collisions to ensure safe operation.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
• Manufacturer (Section D): MAQUET SUZHOU CO. LTD; suzhou ; CH
• Manufacturer (Section G): MAQUET SUZHOU COMPANY LTD; no.158 fang zhou road; suzhou industrial park; suzhou 2150 24; CH 215024
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3647616
• MDR Text Key: 4194793
• Report Number: 3007417753-2014-00001
• Device Sequence Number: 1
• Product Code: FQP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/10/2014,12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• 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: 12/19/2013
• Device Age: 11 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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