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

Device Problem Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reached out regarding a recent flight with a patient on our cardiosave pump.During the flight from wisconsin to iowa they had significant radio interference and ¿lost all communication¿.It is unknown of the patients well being.

Manufacturer Narrative

Updated fields: b4,e1(site country),g3,g6,h2,h6(type of investigation, investigation findings, investigation conclusions),h10.It was reported that the cardiosave intra-aortic balloon pump (iabp) unit during the flight from wisconsin to iowa had significant radio interference and lost all communication.Per voice mail from customer: "the balloon pump was fine, there was nothing wrong with the balloon pump at all.We lost our radio communication due to what our pilot thought was the position of the antenna of the radio and the pump itself.Possibly the wiring of the aircraft.There is no fault log that you need to look at for the balloon pump.Status of the balloon pump is that it is still in service.There was no issue with it at all.The team tried to duplicate the issue by taking the aircraft, the balloon pump and the pacer up to test it.Everything worked fine.They did not have any radio communication issues.".

Event Description

N/a.

• Brand Name: CARDIOSAVE
• 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: 15047880
• MDR Text Key: 304458236
• Report Number: 2249723-2022-01762
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1