ESOPHAGEAL STETHOSCOPE * ES400-18

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-19 for ESOPHAGEAL STETHOSCOPE * ES400-18 manufactured by Respiratory Support Products, Inc..

Event Text Entries

[77484] The esophageal stethoscope male luer connection was mistaken for a similar connection of an oxygen delivery device. The oxygen flow immediately inflated the stethoscope membrane and ruptured it. The force caused an esophagus perforation that required surgical repair. At the end of on orthopedic procedure, the 62 y/o female pt, weight unreported, became agitated. The crna mistakenly administered oxygen (flow: 6 liters/minute) to the pt through the esophageal stethoscope instead of through the nasal clip. The nasal clip had a clear tapered male luer connector on it. [the esophageal stethoscope has a white male luer connector on it. The connector on the oxygen hose is green. ] the crna noticed the mistake immediately. When the esophageal stethoscope was removed, the crna noticed blood on it, but discarded the device. During the pt's stay in the recovery room, it was observed that she was having difficulty breathing and lung sounds were reduced. An esophageal x-ray showed a blur. A thoracotomy was performed. There was a tear in the esophagus. The esophageal tear was clean and easy to suture. Antibiotics were administered immediately during surgery. The pt was released from hospital 10/29/97. After the diagnosis, the crna returned to the or where the procedure was performed and retrieved the esophageal stethoscope from the surgical debris. She observed a split in the balloon. She again threw the esophageal stethoscope in the trash. She reported the split in the esophagel stethoscope to hospital personnel.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 134195
• MDR Report Key: 134195
• Date Received: 1997-11-19
• Date of Report: 1997-10-26
• Date of Event: 1997-10-20
• Date Facility Aware: 1997-10-20
• Report Date: 1997-10-26
• Date Reported to Mfgr: 1997-10-26
• Date Added to Maude: 1997-11-25
• 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: 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: ESOPHAGEAL STETHOSCOPE
• Generic Name: STETHOSCOPE, ESOPHAGEAL
• Product Code: BZW
• Date Received: 1997-11-19
• Model Number: *
• Catalog Number: ES400-18
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 131129
• Manufacturer: RESPIRATORY SUPPORT PRODUCTS, INC.
• Manufacturer Address: 2552 MCGAW AVE. IRVINE CA 92614 US
• Baseline Brand Name: ESOPHAGEAL STETHOSCOPE
• Baseline Generic Name: STETHOSCOPE, ESOPHAGEAL
• Baseline Model No: *
• Baseline Catalog No: ES400-18
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1997-11-19