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

Model Number 0998-00-0800-55

Device Problem Failure to Read Input Signal (1581)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Not returned to manufacturer.

Event Description

It was reported that during training, the cardiosave intra-aortic balloon pump (iabp) the touch lower screen in the display was not working.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Corrected fields: g1 (contact person), h6 (investigation type, investigation findings, component codes & investigation conclusions).A getinge field service engineer (fse) evaluated the iabp and confirmed the reported issue.To address the issue the fse replaced the lcd 19 inch touch 5 wire and display,upper hinge cover.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID INT TYPE E/F 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: 12350766
• MDR Text Key: 267664542
• Report Number: 2249723-2021-01884
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.