SHERIDAN SIZE 7-1/2/ UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-13 for SHERIDAN SIZE 7-1/2/ UNKNOWN manufactured by Sheridan Catheter Corp..

Event Text Entries

[2286] Patient intubated by ems while enroute to emergency room. Admitted in respiratory failure, sepsis secondary to pneumonia, history of multiple sclerosis. Physician initially noted et tube in place, cuff fully inflated. Several hours later, physician initially noted et tube cuff would not remain inflated. Patient immediately re-intubated without complication. Patient expired due to sepsis. Please note, et tube supplied by ems. Ems notified of problem post-incidentdevice 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, performance tests performed. Results of evaluation: none or unknown. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3178
• MDR Report Key: 3178
• Date Received: 1992-07-13
• Date of Report: 1992-03-18
• Date of Event: 1992-03-05
• Date Facility Aware: 1992-03-06
• Report Date: 1992-03-18
• Date Reported to Mfgr: 1992-03-18
• Date Added to Maude: 1993-04-09
• 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: SHERIDAN
• Generic Name: ENDO-TRACHEAL TUBE W/CUFF
• Product Code: LNZ
• Date Received: 1992-07-13
• Model Number: SIZE 7-1/2/
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2967
• Manufacturer: SHERIDAN CATHETER CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-13