MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR ALM-X-TEN; LIGHT, SURGICAL, CEILING MOUNTED

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 04/13/2017

Event Type  malfunction  

Event Description

Entire overhead light broke off from hinge and fell on patient and or nurse.Dr was alerted and xrays were done.No injuries.

• Brand Name: ALM-X-TEN
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET CARDIOVASCULAR; dennis genito; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 6803662
• MDR Text Key: 83026041
• Report Number: 6803662
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/09/2017,07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 567815999
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR