MalfunctionDSP
CARDIOSAVE HYBRID, TYPE G PLUG
Received Jul 30, 2026 · Event occurred Jul 10, 2026
Report 2249723-2026-0003662 · MDR key 50080882
Device
Generic name
System, Balloon, Intra-aortic And Control
Manufacturer
Datascope Corp.Model number
0998-00-0800-52Catalog number
0998-00-0800-52
Product problems
- Failure to Read Input Signal
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported by customer that during clinical use the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) fiber optic sensor failure. Patient involved, no harm reported. Getinge fiber optic balloon was used. No parts were replaced Fault code 53 occurred on first visit and the phrase "Fiber Optic Sensor Failure" with yellow text color warning also occurred.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.