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 Failure to Power Up (1476)

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

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the cardiosave intra-aortic balloon pump (iabp) would not power on while it was plugged into wall.There was no harm reported.

Manufacturer Narrative

Corrected data: b5, b6, b7, d10, h6 (impact code).Updated data: b4, g3, g6, h2, h10, h11.

Event Description

It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) would not power on while it was plugged into wall.There was no patient involved.

Manufacturer Narrative

The field service engineer (fse) stated that after talking with biomed, the transport unit was found to be out of the cart, not allowing it to charge the batteries.So after re-inserting the transport into the cart the batteries started charging.The unit passed all functional testing.No onsite visit was required and it was worked out over the phone.

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: 19099599
• MDR Text Key: 340117764
• Report Number: 2249723-2024-01528
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/29/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/16/2024; 04/29/2024
• Supplement Dates FDA Received: 04/18/2024; 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.