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 No Device Output (1435)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) units printer is not working.

Event Description

It was reported that during installation by a getinge field service engineer (gfse), the cardiosave intra-aortic balloon pump (iabp) units printer is not working.There was no patient involvement.

Manufacturer Narrative

It was reported that during installation getinge field service engineer (fse) found the printer to not be functional on cardiosave intra-aortic balloon pump (iabp).There was no patient involvement and no patient harm reported.Fse replaced defective printer and performed all installation and functional checks.Unit has passed all test and calibrations and is now ready for clinical use.The failure analysis and testing dept.Received part number 0161-00-0024-04 rev.D, serial number (b)(6) , with a reported unit failure of the printer not working.The fat performed a visual inspection and found the part to be in good condition.The fat installed the printer in cardiosave test fixture serial number (b)(6) and tested the part to factory specifications per the cardiosave service manual part number 0070-00-0639 revision r.It was found that the printer would not print properly.Fat confirmed the failure but no root cause identified.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

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: 17799448
• MDR Text Key: 324048598
• Report Number: 2249723-2023-04166
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2024

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: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/05/2023; 05/08/2024
• Supplement Dates FDA Received: 10/06/2023; 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1