REICHERT 14364 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-05 for REICHERT 14364 * manufactured by Reichert Ophthalmic Instruments.

Event Text Entries

[424010] The patient was sitting upright in the ophthalmic chair with the slit lamp table over her legs. The physician pushed the button to raise the chair into position for the eye examination. The chair began to rise and continued to rise after the button was released. The physician noted that the button was stuck. The patient's knee was caught between the chair and the slit lamp table. The technician unplugged the power cord to the chair, then plugged the power cord back in. The physician pushed the button to lower the chair. The chair lowered, releasing the patient's leg.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 646973
• MDR Report Key: 646973
• Date Received: 2005-11-05
• Date of Report: 2005-11-05
• Date of Event: 2005-09-08
• Report Date: 2005-11-05
• Date Reported to FDA: 2005-11-05
• Date Added to Maude: 2005-11-22
• 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 Sequence Number: 1

• Brand Name: REICHERT
• Generic Name: OPHTHALMIC CONSOLE
• Product Code: HKO
• Date Received: 2005-11-05
• Model Number: 14364
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 13 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 636462
• Manufacturer: REICHERT OPHTHALMIC INSTRUMENTS
• Manufacturer Address: 3374 WALDEN AVE DEPEW NY 14043 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: OPHTHALMIC CHAIR
• Product Code: HME
• Date Received: 2005-11-05
• Model Number: 14360
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 13 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 636463
• Manufacturer: REICHERT OPHTHALMIC INSTRUMENTS
• Manufacturer Address: 3374 WALDEN AVE DEPEW NY 14043 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-11-05