MalfunctionBSZ
ADU
Received Jun 17, 2026 · Event occurred May 21, 2026
Report 9610105-2026-00002 · MDR key 25537573
Device
Product problems
- Increase in Pressure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UNIT WAS AT END OF LIFE. NO REPAIR COMPLETED. BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. BLOCK H4: DATE OF DEVICE MANUFACTURE YEAR IS 2000. THE MONTH OF MANUFACTURE WAS AUGUST. LEGAL MANUFACTURER: HCS HELSINKI - KUORTANEENKATU 2 FINLAND HELSINKI ETELA-SUOMEN LAANI, FIN-00510.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN PROLONGED EXCESSIVE PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.