MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that while in stand by mode, the cardiosave intra-aortic balloon pump (iabp) helium tank empties.There was no patient involved.

Manufacturer Narrative

Updated fields: (event site postal code - (b)(6).A getinge field service engineer (fse) evaluated and stated that high helium leak coming from the high pressure reducer.Fse replaced helium high pressure regulator.After replacement, leaks fell within the standard parameters.Operational tests carried out with positive results.The unit was cleared for clinical use.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID W/ E/F PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 18536577
• MDR Text Key: 333348540
• Report Number: 2249723-2024-00228
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1