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 Problem Failure to Read Input Signal (1581)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Upon initial inspection, the fse found multiple catheter restriction errors.In addition, a broken low level output cable was found.This explains the customers complaints about faulty leads and no pressure.The fse continued to a complete system checkout and found no problems with the unit.Unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.The fse will offer a quote to customer to purchase new leads and cables.Upon completion of our investigation, a supplemental report will be submitted.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was not reading the pressure due to faulty leads.It is unknown under which circumstances this event occurred.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was not reading the pressure due to faulty leads.There was no patient harm or injury reported.

Manufacturer Narrative

Updated fields; b4, g3, g6, g7, h2, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected fields: b5, b6, b7, g1, h6 (health effect ¿ impact codes, component codes).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was not reading the pressure due to faulty leads.It is unknown under which circumstances this event occurred or if there was any patient involvement, however no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h10, h11.Corrected fields: b5, h6(clinical code, component codes & impact codes).It was confirmed that cables were replaced.

• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12051264
• MDR Text Key: 265563609
• Report Number: 2249723-2021-01332
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose