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

Model Number 0998-00-0800-45

Device Problem No Device Output (1435)

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

Event Date 10/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) unit's printer was not working.Rn icu calls to report a printer will not print on a cardiosave.It had been printing without issue every hour for the last 1-2 days.She states they were not changing out paper or changing settings and it just stopped printing.Printer would not respond to ¿print strip¿ command.All attempts and resuming print were unsuccessful.She did not wish to shut down and reboot the cardiosave.Therapy uninterrupted.There was no harm to patient.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings and investigation conclusions), h10, h11.Corrected fields: d1, d4 (version or model, catalog & udi).A getinge field service engineer (fse) confirmed with biomed that the printer is working fine.Nurse loaded the printer paper backwards which is why the strips weren't printed.Unit is currently still in use.H3 other text : no repair needed.

• Brand Name: CARDIOSAVE HYBRID, TYPE I 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: 18092611
• MDR Text Key: 327634422
• Report Number: 2249723-2023-04766
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1