UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-25 for UNKNOWN manufactured by Chemetron Medical Products.

Event Text Entries

[21630473] Oxygen flow meter was found to be "plugged in" a nitrous oxide outlet. Flow was found to be available. There is no evidence to suggest patients have ever received nitrous oxide. There is no evidence to suggest that oxygen flow meter was ever used. Examination demonstrates connector has a break in metal and plastic component which allows connection to enter nitrous oxidedevice not labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: design - human factors. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1205
• MDR Report Key: 1205
• Date Received: 1992-08-25
• Date of Report: 1992-07-24
• Date of Event: 1992-07-16
• Date Facility Aware: 1992-07-16
• Report Date: 1992-07-24
• Date Reported to FDA: 1992-07-24
• Date Reported to Mfgr: 1992-07-24
• Date Added to Maude: 1992-09-02
• 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
• Health Professional: 0
• Initial Report to FDA: 0
• 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: UNKNOWN
• Generic Name: OXYGEN FLOW METER
• Product Code: BXY
• Date Received: 1992-08-25
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: 2982135
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1153
• Manufacturer: CHEMETRON MEDICAL PRODUCTS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-25