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

Model Number 0998-00-0800-33

Device Problem Failure to Zero (1683)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported during a routine check performed by the customer, the cardiosave intra-aortic balloon pump (iabp) user was unable to perform zeroing on the ibp line.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6, h10.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the issue was user error.The end user did not properly use the screen, and the unit was unable to be zeroed.The unit passed all functional and safety tests and was returned to customer in working condition.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE D 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: 18832031
• MDR Text Key: 336876178
• Report Number: 2249723-2024-00917
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109008
• UDI-Public: 10607567109008
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-33
• Device Catalogue Number: 0998-00-0800-33
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.