MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-83

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced cable as listed.All functional and safety checks were to met factory specifications.The iabp unit was 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 by the customer that the cardiosave intra-aortic balloon pump (iabp) unit has a ecg capture issue.It is unknown under which circumstances this event occurred; however there was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval), g3, g6, g7, h2, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h11.Corrected fields: g1(contact person), h10.A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the ecg lead and ecd trunk cables.All functional and safety checks were to met factory specifications.The iabp unit was returned to the customer and cleared for clinical use.

Event Description

N/a.

• Brand Name: CARDIOSAVE RESCUE
• 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: 13078506
• MDR Text Key: 286866137
• Report Number: 2249723-2021-02945
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: 10607567108407
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1