OR1 NEO IP, BAS-REM 2.5
Received Aug 15, 2025 · Event occurred Jul 22, 2025
Report 9610617-2025-01395 · MDR key 22816149
Device
Generic name
Or1 Neo Ip, Bas-rem 2.5
Manufacturer
Karl Storz Se & Co. KgModel number
WUIS2913-01Catalog number
WUIS2913-01
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE MONITOR SIGNAL ON BOOM WAS FROZEN DURING THE END OF AN OPEN-HEART CASE. THE VITALS LOOKED GOOD. OTHER DISPLAYS HAD A DIFFERENT READING. UNABLE TO RECREATE FAILURE AND NEEDED TO REOPEN PATIENT'S CHEST TO CLARIFY.
Additional Manufacturer Narrative
THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, WE WILL SEND OUR SERVICE TECH TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS PRODUCT IS MANUFACTURED AT KARL STORZ ENDOSCOPY AMERICA, 13803 N PROMENADE BLVD, STAFFORD, TX 77477; HOWEVER, IT IS DESIGNED IN GERMANY. THEREFORE, AN IMPORTER IS NOT REQUIRED FOR THIS EVENT. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).