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

Model Number 0998-00-0800-65

Device Problem Mechanical Problem (1384)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted when additional information is provided.(b)(6).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) "docking of the cart and the main body did not go well." it is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, b6, b7, d11, g4, g7, h2, h6 (type of investigation and component codes), h10, h11.Corrected fields: b5, d4 (version number/model number, catalog #, and udi number should be blank), e4, g1, g3.Testing of actual/suspected device (10/213): the getinge field service engineer (fse) resolved the issue by adjusting the connection between the console and the cart.The fse successfully performed functional and safety checks to meet factory specifications.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during an initial inspection of the cardiosave intra-aortic balloon pump (iabp) at getinge's service center prior to delivery to the customer facility, there was a connection failure between the console and the cart.Therefore, the iabp was retained at the service center and another iabp unit was delivered to the customer.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, g8, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person), h4, h6(component codes).

Event Description

N/a.

• 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: 11443659
• MDR Text Key: 240390304
• Report Number: 2249723-2021-00465
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1