MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-52

Device Problem Restricted Flow rate (1248)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.E1 event site name was shortened due to character limitations.The complete name is (b)(6).

Event Description

It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) had a catheter restriction.No patient harm or injury.

Manufacturer Narrative

Corrected data: b5, b6, b7, d10, h6 (impact code).Updated data: b4, g3, g6, h2, h10, h11.

Event Description

It was reported that during setting up, the cardiosave intra-aortic balloon pump (iabp) had a catheter restriction and they realized the device was not inflating.There was no patient involved.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and drive regulator spec going to be out of range soon.The fse calibrated drive regulator and tested unit according to checklist.Run on balloon for 30mins and no issue found.The fse was unable to replicate fault.The fse completed safety, functionality, and calibration checks and all tests passed to factory specifications.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 18735483
• MDR Text Key: 336097998
• Report Number: 2249723-2024-00723
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1