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

Model Number 0998-00-0800-52

Device Problems Battery Problem (2885); Unexpected Shutdown (4019)

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

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.E1.Initial reporter was shortened due to character limitations.The complete name is: (b)(6).

Event Description

It was reported by a getinge field service engineer (gfse) that the newly installed cardiosave intra-aortic balloon pump (iabp) that was not yet handed over to the customer failed for the battery test.In the display battery status indicator showing fully charged as well as battery charge indicator.Once try to run the device in the battery, sudden shutdown occurring.There was no patient involvement.

Manufacturer Narrative

Corrected data: b5 updated data: b3, b4, g3, g6, h2, h10.

Event Description

It was reported by a getinge field service engineer (gfse) that the newly installed cardiosave intra-aortic balloon pump (iabp) that was not yet handed over to the customer failed for the battery test.After installation all tests were passed , but during the inspection with the customer found one battery , defective.The display battery status indicator showing fully charged as well as battery charge indicator.Once try to run the device in the battery, sudden shutdown occurring.There was no patient involvement.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 18958035
• MDR Text Key: 338339337
• Report Number: 2249723-2024-01225
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Date Manufacturer Received: 03/08/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1