CRANE CRANE II ASSEMBLY NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-13 for CRANE CRANE II ASSEMBLY NA manufactured by Nomos Corporation.

Event Text Entries

[329061] Pt in for radiation. Head, neck ca, unknown primary site. After treatment it was noted the bed had not moved and received radiation in one spot instead of several. Admitted to hosp for observation, given decadrons in case of seizures. Discharged with no apparent effect. M. D. Calculated pt received 30% of radiation than initially thought. The nomos was not securely fastened even though it felt tight.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 540451
• MDR Report Key: 540451
• Date Received: 2004-08-13
• Date of Report: 2004-08-12
• Date of Event: 2004-08-04
• Date Facility Aware: 2004-08-04
• Report Date: 2004-08-12
• Date Reported to FDA: 2004-08-12
• Date Reported to Mfgr: 2004-08-12
• Date Added to Maude: 2004-08-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CRANE
• Generic Name: PATIENT POSITIONING DEVICE
• Product Code: IWY
• Date Received: 2004-08-13
• Model Number: CRANE II ASSEMBLY
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1.5 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 529760
• Manufacturer: NOMOS CORPORATION
• Manufacturer Address: 200 W. KENSINGER DR. #100 CRANBERRY TOWNSHIP PA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2004-08-13