RAM MARK 2 PSS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2005-02-14 for RAM MARK 2 PSS * manufactured by Elekta Limited.

Event Text Entries

[344814] While lowering the bed to unload a patient, the table top tilted and slammed back down. The bed then mechanically dropped approximately 30cm. The table was immediately taken out of service pending service.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9617016-2005-00006
• MDR Report Key: 576503
• Report Source: 06,08
• Date Received: 2005-02-14
• Date of Report: 2005-02-14
• Date of Event: 2005-01-11
• Date Mfgr Received: 2005-01-20
• Device Manufacturer Date: 1980-01-01
• Date Added to Maude: 2005-03-01
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: LINAC HOUSE, FLEMING WAY
• Manufacturer City: CRAWLEY, WEST SUSSEX RH109RR
• Manufacturer Country: UK
• Manufacturer Postal: RH10 9RR
• Manufacturer Phone: 4412936542
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RAM MARK 2 PSS
• Generic Name: TABLETOP
• Product Code: INQ
• Date Received: 2005-02-14
• Model Number: *
• Catalog Number: *
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 566342
• Manufacturer: ELEKTA LIMITED
• Manufacturer Address: LINAC HOUSE, FLEMING WAY CRAWLEY, WEST SUSSEX UK RH10 9RR

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-02-14