MAUDE Adverse Event Report: MAQUET S.A. MODUTEC; TUBING, PRESSURE AND ACCESSORIES

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

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2010

Event Type  malfunction  

Event Description

Reference importer report number (b)(4).

Manufacturer Narrative

Maquet determined that the only way the end cap could detach would be if the two fastening screws which secure it to the boom arm were not in place.It is part of the modutec series yearly preventive maintenance to verify that the beam covers are firmly in place.The user informed the maquet sales rep that she did not know who repaired the device or when it occurred, but the pendant in operating room #11 is repaired.(b)(4).

• Brand Name: MODUTEC
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): MAQUET S.A.; orleans ; FR
• Manufacturer Contact: marie-francoise cabel ; avenue de la pomme de pin cs 10008 ardon; parc de limere; orleans cedex 2 45074 ; FR 45074 ; 37013004
• MDR Report Key: 4669501
• MDR Text Key: 17938314
• Report Number: 9710055-2015-00034
• 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: Health Professional,User Facility,Company Representative
• 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
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other