MalfunctionBZW
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE
Received Mar 9, 2001 · Event occurred Feb 1, 2001
Report 2020364-2001-00001 · MDR key 320037
Device
Generic name
Esophageal Stethoscope
Manufacturer
Sims Portex Inc.Model number
NACatalog number
ES400-12, ES400-18, ES400-24
Lot number
1382
Product problems
- Dislodged
Patient
NO INFO
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
AN ESOPHAGEAL STETHOSCOPE WAS USED DURING SURGERY. ONE DAY POST-OP, THE PT ALLEGEDLY COUGHED UP THE BALLOON THAT WAS ATTACHED TO THE DISTAL END OF THE ESOPHAGEAL STETHOSCOPE. THE HOSPITAL STAFF WERE REPORTEDLY UNAWARE OF ANY PROBLEMS PRIOR THE PT COUGHING UP THE BALLOON.