MAUDE Adverse Event Report: MAQUET SAS MODUTEC; TUBING, PRESSURE AND ACCESSORIES

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Concussion (2192)

Event Date 09/16/2010

Event Type  Injury  

Event Description

Customer reported to maquet sales rep about an injury involving an unspecified maquet boom in the operating room #11.The nurse educator reported that she was hit in the head by a falling blue end cap.She also stated that she received a concussion that took two years to recover from.She did not give any more details on the injury.Factory reference number: (b)(4).Mfr reference number 9710055-2015-00034.

• Brand Name: MODUTEC
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): MAQUET SAS; orleans ; FR
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4669503
• MDR Text Key: 5604123
• Report Number: 3008355164-2015-00063
• Device Sequence Number: 1
• Product Code: BYX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other