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

Model Number 0998-00-0800-45

Device Problem Overheating of Device (1437)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device : an authorized getinge dealer engineer was dispatched to investigate.The engineer evaluated the iabp unit, but was unable to reproduce the reported issue.The fse performed functional and safety checks to meet factory specifications.The iabp was then released to the customer, however, not cleared for clinical service.Repairs are ongoing, and a supplemental report will be submitted upon completion of our investigation.The full event site name in is (b)(6).

Event Description

It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) alarmed "system temperature is too high," and continued to alarm even after the end user re-started the unit.No patient harm, serious injury or adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

An authorized getinge dealer engineer was dispatched to investigate.The engineer evaluated the iabp unit, but was unable to reproduce the reported issue.The fse performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.

• Brand Name: CARDIOSAVE HYBRID TYPE I 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: 12452427
• MDR Text Key: 270866342
• Report Number: 2249723-2021-02041
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Sex: Prefer Not To Disclose