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

Model Number 0998-00-0800-53

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

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

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.Upon inspection by the fse, no failure could be reproduced.This unit passed all functional and safety tests per factory specifications.The iabp unit has been returned to the customer and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during patient use the cardiosave intra-aortic balloon pump (iabp) had a fiber optic module failure.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, b5, d11, g4, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: h6 (problem code).

Event Description

It was reported that during patient use the cardiosave intra-aortic balloon pump (iabp) had a fiber optic module failure.It was later clarified by the customer that it was an iab sensor failure.There was no harm or injury to the patient and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID, TYPE B 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12835749
• MDR Text Key: 282722034
• Report Number: 2249723-2021-02669
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON CATHETER