OMNIBATCH 10 BW *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-09 for OMNIBATCH 10 BW * manufactured by X-rite.

Event Text Entries

[201614] Exposed to chemical fumes emitted from equipment that malfunctioned in a darkroom in the radiology dept. Symptoms included numbness in face. Breathing difficulties. Equipment removed from hosp. Odor dissipated. Sulfur gas emitted. Air tested for h2s, results negative. Employee became a pt seen in er, treated and released.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 304183
• MDR Report Key: 304183
• Date Received: 2000-11-09
• Date of Report: 2000-11-08
• Date of Event: 2000-10-30
• Date Facility Aware: 2000-10-30
• Report Date: 2000-11-08
• Date Reported to FDA: 2000-11-08
• Date Reported to Mfgr: 2000-11-08
• Date Added to Maude: 2000-11-15
• 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: OMNIBATCH 10 BW
• Generic Name: SAFETY KLEEN SLIVER RECOVERY UNIT
• Product Code: IXW
• Date Received: 2000-11-09
• Returned To Mfg: 2000-10-30
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 294367
• Manufacturer: X-RITE
• Manufacturer Address: 44TH ST SW GRANDVILLE MI 494182357 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-11-09