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 Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported to the getinge field service engineer (gfse) while on site servicing another unit, that the cardiosave intra-aortic balloon pump (iabp) unit would not slave out to the patient monitor.

Manufacturer Narrative

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

Manufacturer Narrative

Complaint record being cancelled as it is a duplicate to tw# (b)(4);mfg report number 2249723-2024-00388.Revert all sections to blank : b.Adverse event or product problem; d.Suspect medical device; e.Initial reporter g.All manufacturers; h.Device manufacturers only.

Event Description

Complaint record being cancelled as it is a duplicate to tw# (b)(4);mfg report number 2249723-2024-00388.

Event Description

It was reported to the getinge field service engineer (gfse) while on site during a routine testing of the unit, that the cardiosave intra-aortic balloon pump (iabp) unit would not slave out to the patient monitor.There was 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: 18686887
• MDR Text Key: 335143716
• Report Number: 2249723-2024-00587
• Device Sequence Number: 1
• Product Code: DSP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/20/2024; 03/15/2024
• Supplement Dates FDA Received: 02/22/2024; 03/15/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1