OR1 NEO IP, ENH2
Received Jun 17, 2022 · Event occurred May 24, 2022
Report 9610617-2022-00097 · MDR key 14733266
Device
Generic name
Neo Ip Controller
Manufacturer
Karl Storz Se & Co. KgModel number
WUIS2548Catalog number
WUIS2548
Product problems
- Temperature Problem
- Temperature Problem
Patient
Male
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
CUSTOMER REPORTED A UPS OVERHEATING ALARM ON THE INTEGRATION RACK, AND WHEN THE BIOMED WAS INSPECTING THE EQUIPMENT, HE REACHED ACROSS THE BACK OF THE EQUIPMENT ON THE RACK AND RECEIVED A 2ND DEGREE BURN ON HIS ARM.
Additional Manufacturer Narrative
THE EQUIPMENT WILL BE INSPECTED ONSITE, AND A SUPPLEMENT REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
OUR TECHNICIAN WAS UNABLE TO INSPECT THE EQUIPMENT, AS THE CUSTOMER DECIDED THAT THEY DID NOT WANT AN ONSITE VISIT FOR THIS CASE. THEREFORE, A CAUSE FOR THE OVERHEATING ISSUE COULD NOT BE DETERMINED.