MAYFIELD HEAD REST OMI 957 001 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-16 for MAYFIELD HEAD REST OMI 957 001 * manufactured by Ohio Medical Instruments.

Event Text Entries

[128391] Mayfield head rest for traction, device became unsteady. Rptr tried to adjust head rest and weights, in doing so, head and neck flexed. Pt in surgery for c7 - t1 - "sablu". Device will be sent to independent lab for testing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 219301
• MDR Report Key: 219301
• Date Received: 1999-04-16
• Date of Report: 1999-04-14
• Date of Event: 1999-03-31
• Date Facility Aware: 1999-04-04
• Report Date: 1999-04-15
• Date Reported to FDA: 1999-04-15
• Date Reported to Mfgr: 1999-04-15
• Date Added to Maude: 1999-04-20
• 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: 0
• 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: MAYFIELD HEAD REST
• Generic Name: USED FOR TRACTION
• Product Code: HBM
• Date Received: 1999-04-16
• Model Number: OMI 957 001
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 212674
• Manufacturer: OHIO MEDICAL INSTRUMENTS
• Manufacturer Address: 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	1999-04-16