MalfunctionBZW
SONATEMP ESOPHAGEAL STETHOSCOPE SERIES 400
Received Apr 21, 2000 · Event occurred Mar 23, 2000
Report 1317749-2000-00002 · MDR key 275074
Device
Generic name
Esophageal Stethoscope
Manufacturer
Kendal HealthcareModel number
*Catalog number
5-13218
Lot number
104955
Product problems
- Component(s), broken
- Dislodged
- Difficult to Remove
Patient
*
- Vomiting
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
QA MANAGEMENT OF MEDICAL CENTER REPORTS TO SALES REP OF MANUFACTURER THAT A PATIENT WAS USING AN ESOPHAGEAL STETHOSCOPE MANUFACTURED BY THE MFR. UPON REMOVAL OF PRODUCT, CUSTOMER ALLEGES THE END CAP OF PRODUCT HAD DISLODGED FROM THE MAIN ESOPHAGEAL STETHOSCOPE. TWENTY-FOUR HOURS LATER, THE PATIENT VOMITED UP THE END PIECE OF THE STETHOSCOPE. AS A RESULT, THE PATIENT REMAINED IN HOSPITAL FOR OBSERVATION AND A FULL SERIES OF X-RAYS. NO PATIENT INJURY WAS NOTED.