TRACH "T" ADAPTER P001500 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-01 for TRACH "T" ADAPTER P001500 N/A manufactured by Airlife.

Event Text Entries

[2711] Patient arrived in post anesthesia recovery unit after vaginal hysterectomy and lysis of adhesions. After device was placed on patient per description below, patient developed high intrathoracic pressure with subsequent bilateral pneumothorax and subcutaneous emphysema. Bilateral chest tubes were placed. Both lungs were re-expanded. Patient was observed for one day in icu. Patient was discharged four days post-incident in stable and good conditioninvalid 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: 4479
• MDR Report Key: 4479
• Date Received: 1992-07-01
• Date of Report: 1992-04-14
• Report Date: 1992-04-14
• Date Reported to FDA: 1992-04-14
• Date Added to Maude: 1993-05-26
• 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: TRACH "T" ADAPTER
• Product Code: FKB
• Date Received: 1992-07-01
• Model Number: P001500
• Catalog Number: N/A
• Lot Number: N/A
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4199
• Manufacturer: AIRLIFE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1992-07-01