BLUE LINE 197085

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-31 for BLUE LINE 197085 manufactured by Concord Portex.

Event Text Entries

[19234962] Ventilator low pressure alarm went off. Source of alarm could not be determined. Patient was extubated had re-intubated. Respiratory therapist noted that balloon of endotracheal tube was ruptured cpr was initiated. Paitnet did not survivedevice labeled for single use. Patient medical status prior to event: critical condition. There was not 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 used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, unanticipated long term complication of procedure, other, other. Conclusion: device discarded - unable to follow-up. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6437
• MDR Report Key: 6437
• Date Received: 1993-08-31
• Date of Report: 1993-08-03
• Date of Event: 1993-07-22
• Date Facility Aware: 1993-07-22
• Report Date: 1993-08-03
• Date Reported to FDA: 1993-08-03
• Date Added to Maude: 1993-09-13
• 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: BLUE LINE
• Generic Name: ENDOTRACTHEAL TUBE
• Product Code: LNZ
• Date Received: 1993-08-31
• Catalog Number: 197085
• Lot Number: 304011
• Device Expiration Date: 1998-04-01
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6126
• Manufacturer: CONCORD PORTEX

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-08-31