SHILEY LOW PRESSURE TRACH TUBE - INNER CANNULA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-01 for SHILEY LOW PRESSURE TRACH TUBE - INNER CANNULA * manufactured by Malinckrodt Medical Tpi, Inc..

Event Text Entries

[25675] Pt observed to be cyanotic, bradycardic and unresponsive. Pt was removed from ventilator and was unable to be ventilated with ambu bag. The inner cannula in trach tube was noted to be kinked. Inner cannula was unkinked, secured and pt bagged on 100% o2. Pt placed back on mechanical ventilation. Pt suffered no untoward effects.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 35440
• MDR Report Key: 35440
• Date Received: 1996-07-01
• Date of Report: 1996-02-19
• Date of Event: 1996-02-04
• Date Facility Aware: 1996-02-04
• Report Date: 1996-02-19
• Date Reported to Mfgr: 1996-02-19
• Date Added to Maude: 1996-08-19
• 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: SHILEY LOW PRESSURE TRACH TUBE - INNER CANNULA
• Generic Name: LOW PRESSURE TRACH TUBE - INNER CANNULA
• Product Code: BRT
• Date Received: 1996-07-01
• Model Number: *
• Catalog Number: *
• Lot Number: M52338000
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 6 MO
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 36858
• Manufacturer: MALINCKRODT MEDICAL TPI, INC.
• Manufacturer Address: 1595 DERRE AVE PO BOX 19614 IRVINE CA 927139614 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	1996-07-01