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

Model Number 0998-00-0800-53

Device Problem Output below Specifications (3004)

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

Event Date 02/10/2022

Event Type  malfunction  

Manufacturer Narrative

The full name of the event site was shortened due to field character limit; the full name is (b)(6) medical center.Communications/ interviews: biomed was assisted in printing out an alarm history strip to review all alarms.After a quick review, the biomed realized the pump did not alarm ¿constantly¿ with different issues.The helium gauge showed the tank was half full while the icon says ¿low¿ in red.Biomed was assisted to open the tank fully and to go by the gauge versus the computer screen icon.Cs explained how many auto-fills they would have once the gauge showed ¿in the red¿.Two helium tanks were provided by the customer to have bedside while the patient continued therapy.A supplemental report will be submitted upon completion of our investigation.Not returned to manufacturer.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) gave a low helium alarm.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp.Additional information was requested from the customer with regard to the repair and status of the iabp; however, despite our best efforts, no repair information and no status of the iabp has been received.If any pertinent information is received in the future, a supplemental report will be submitted.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE B 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: 13694969
• MDR Text Key: 288860889
• Report Number: 2249723-2022-00480
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/08/2022; 02/01/2024
• Supplement Dates FDA Received: 04/04/2022; 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MAQUET BALLOON.