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 No Display/Image (1183)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer evaluated the unit and could not reproduce the reported issue however the fse identified codes 111 and 112 in unit logs.To resolve the issue the fse replaced the coiled cord and back plane board cord.The iabp passed all functional and safety tests to meet factory specifications.The unit was returned to the customer and cleared for clinical use.A supplemental report will be submitted upon completion of the investigation.Full event site name: (b)(6) medical center.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) display stopped working.The unit was swapped out with another to continue therapy without incident.No patient harm, serious injury or adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6, h10.Inspection of the cable,backplane to coiled cord was completed per the cardiosave service manual with no visual damage observed.Inspection of the cable, coiled cord was completed per the cardiosave service manual part number with no visual damage observed.The nrc installed both cables into the cardiosave test fixture and tested the cables per the cardiosave service manual.The nrc could not verify the error codes 111 and 112 after an extended run time of the cardiosave.The cables passed testing.Retaining the cables in the nrc.

• 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: 12566634
• MDR Text Key: 274452610
• Report Number: 2249723-2021-02240
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• 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: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR