CARDIOSAVE HYBRID, TYPE B PLUG
Received Jul 29, 2026 · Event occurred Jul 8, 2026
Report 2249723-2026-0003638 · MDR key 50065995
Device
Generic name
System, Balloon, Intra-aortic And Control
Manufacturer
Datascope Corp.Model number
0998-00-0800-53Catalog number
0998-00-0800-53
Product problems
- Pumping Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported by the customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) was continuously putting itself into standby. The unit was swapped with another. There was no patient harm or injury. A Getinge Field Service Engineer (FSE) evaluated the unit, but was unable to confirm the reported malfunction. There were no error or fault logs found. The FSE ran the unit with a trainer and catheter while tapping all around on the touchscreen as well as opening and closing. No problems were found. The unit never went into standby mode. The unit passed all performance and safety tests according to factory specifications.
Additional Manufacturer Narrative
E. Initial Reporter: Event Site Name: (b)(6).