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 Communication or Transmission Problem (2896)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) internal communication failed.

Manufacturer Narrative

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

Event Description

It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) internal communication failed.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, component codes, investigation conclusions), h10.Additional information poc: (b)(6).It was reported that the cardiosave intra-aortic balloon pump (iabp) internal communication failure.Getinge field service engineer (fse internal communication failure was resolved by installing (mca000000618) grommet edging, sheet thickness 0.044 -, cable tie, 3.9 inch / 99 mm 2 ea, standoff ss 4-40 male to 6-32 , screw,pan head,ss 6-32 x 1/4parts.Complete pm with full calibration, functional testing and safety check to factory specifications.Returned to the customer and cleared for customer use.Complete pm, and safety test.Reference so (b)(4) for measurement details.No patient involvement.

• 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: 18049677
• MDR Text Key: 327094352
• Report Number: 2249723-2023-04684
• 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: 04/02/2024

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?: No
• 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: 10/23/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/13/2023; 03/29/2024
• Supplement Dates FDA Received: 11/15/2023; 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.