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

Model Number 0998-00-0800-65

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device : a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and tested the unit by doing the helium pressure test, but the unit was still down 39 psi.The gasket was replaced, tightened the helium cylinder and checked the docking o-ring, but the issue could not be resolved.A supplemental report will be submitted when additional information is provided.The initial reporter named in is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).

Event Description

It was reported that during an inspection the cardiosave intra-aortic balloon pump (iabp) was not passing the helium pressure test.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Additional information: e1(event site postal code: (b)(6).Event site state:(b)(6)).Additional point of contact: (b)(6).

• Brand Name: CARDIOSAVE HYBRID INT 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: 13076891
• MDR Text Key: 282713656
• Report Number: 2249723-2021-02943
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

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: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.