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 Appropriate Term/Code Not Available (3191)

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

Event Date 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: (10/3233) : a getinge field service engineer (fse) evaluated the unit and determined the pneumatic interface module (pim) requires repair.The fse advised the pim part is on back order.A supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported that during a routine check the cardiosave intra-aortic balloon pump (iabp) had a loose pneumatic interface module (pim) connector.There was patient involvement, thus no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the unit and determined the pneumatic interface module (pim) requires repair.The fse advised the pim part is on back order.A supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported that during a routine check the cardiosave intra-aortic balloon pump (iabp) had a loose pneumatic interface module (pim) connector.There was patient involvement, thus no adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) returned to the customer's site and installed a new pneumatic module assembly (pim).The installation of the part repaired the reported issue.Subsequently, the fse completed preventative maintenance (pm) service including all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.The suspected faulty pim is expected to be returned for failure investigation.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields - b4,e1(site country),e2,e3,g3,g6,h2,h4,h6(type of investigation, investigation findings, investigation conclusions),h10,h11.Corrected field - d5,g2.

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: 13563687
• MDR Text Key: 286082694
• Report Number: 2249723-2022-00334
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1