REICHERT/CAMBRIDGE 14364 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-01 for REICHERT/CAMBRIDGE 14364 * manufactured by Reichert Opthalmic Instruments.

Event Text Entries

[385662] The patient was seated upright in the ophthalmology clinic examination chair. The slit lamp microscope table was placed over the patient's legs by the physician in preparation for an eye examination. The physician pushed the button on the ophthalmic console/instrument stand in order to raise the chair to the level needed for the exam. The chair began to rise. The chair continued to rise despite the physician having released the button. The patient's thigh was pinned between the chair and the slit lamp table. A technician in the room unplugged the electrical cord that was connected to the chair via a relay box from the console/stand. The chair stopped rising. The technician then plugged the cord back in, the physician pushed the button for the chair to lower. The chair lowered, releasing the patient's leg.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 627323
• MDR Report Key: 627323
• Date Received: 2005-08-01
• Date of Report: 2005-08-01
• Date of Event: 2005-07-13
• Report Date: 2005-08-01
• Date Reported to FDA: 2005-08-01
• Date Added to Maude: 2005-08-17
• 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/CAMBRIDGE
• Generic Name: OPHTHALMIC CONSOLE
• Date Received: 2005-08-01
• 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: 616949
• Manufacturer: REICHERT OPTHALMIC INSTRUMENTS
• Manufacturer Address: 3374 WALDEN AVENUE DEPEW NY 14043 US

Device Sequence Number: 2

• Brand Name: REICHERT/CAMBRIDGE
• Generic Name: OPHTHALMIC INSTRUMENT STAND
• Product Code: HMF
• Date Received: 2005-08-01
• Model Number: 14363
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 13 YRS
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 616950
• Manufacturer: REICHERT OPHTHALMIC INSTRUMENTS
• Manufacturer Address: 3374 WALDEN AVE DEPEW NY 14043 US

Device Sequence Number: 3

• Brand Name: REICHERT/CAMBRIDGE
• Generic Name: OPHTHALMIC CHAIR
• Product Code: HME
• Date Received: 2005-08-01
• Model Number: 14360
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 13 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 616951
• Manufacturer: REICHERT OPHTHALMIC INSTRUMENTS
• Manufacturer Address: 3374 WALDEN AVE DEPEW NY 14043 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-08-01