HI-LO TRACHEAL TUBE CUFFED, MURPHY EYE 86114

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-24 for HI-LO TRACHEAL TUBE CUFFED, MURPHY EYE 86114 manufactured by Mallinckrodt Anesthesia Products.

Event Text Entries

[1646] Patient with myasthenia gravis developed respiratory arrest. The physician intubated the patient and placement was felt to be correct. However, the patient developed subsequent cardiac arrest and expired. The tube was found in the esophagus on autopsy. Invalid data - regarding single use labeling of device. 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. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4601
• MDR Report Key: 4601
• Date Received: 1992-07-24
• Date Added to Maude: 1993-05-28
• 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: HI-LO TRACHEAL TUBE CUFFED, MURPHY EYE
• Generic Name: ENDOTRACHEAL TUBE
• Product Code: LNZ
• Date Received: 1992-07-24
• Model Number: 86114
• Catalog Number: 86114
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4320
• Manufacturer: MALLINCKRODT ANESTHESIA PRODUCTS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1992-07-24