CARDIOSAVE HYBRID, 3.1 EDITION
Received Jul 29, 2026 · Event occurred Jul 8, 2026
Report 2249723-2026-0003642 · MDR key 50066508
Device
Generic name
System, Balloon, Intra-aortic And Control
Manufacturer
Datascope Corp.Model number
0998-00-0800-65Catalog number
0998-00-0800-65
Product problems
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that during clinical use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a message indicating that maintenance needs to be considered has been generated. There was no patient harm or injury reported. A GETINGE Field Service Engineer (FSE) was dispatched to evaluate the IABP unit and was able to confirm from the Message log Fault # 78 (Exec UI Bridge Sender failed WDT), Fault # 79 (Video HeartBeat Lost) and #80 Video communication error. Running test OK (issue did not recur) and no abnormalities found in IABP. Work performed according to the service manual and Results were good.
Additional Manufacturer Narrative
E. Initial ReporterEvent Site Postal Code: (b)(6).