MAUDE Adverse Event Report: MAQUET / GETINGE ACCESSRAIL PLATFORM

Model Number DB-1000

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/13/2018

Event Type  Injury  

Event Description

Device broke in the process of surgeon attempting to place.

• Brand Name: ACCESSRAIL PLATFORM
• Type of Device: ACCESSRAIL PLATFORM
• Manufacturer (Section D): MAQUET / GETINGE; wayne NJ
• MDR Report Key: 7619111
• MDR Text Key: 111883955
• Report Number: MW5077944
• Device Sequence Number: 1
• Product Code: NQG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Model Number: DB-1000
• Device Lot Number: 25136710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR