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

Model Number 0998-00-0800-52

Device Problem Unable to Obtain Readings (1516)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the screen for the cardiosave intra-aortic balloon pump (iabp) was not showing the signals while operating.The end user swapped out the iabp unit with another iabp unit to continue therapy without issue.There was no patient harm and no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse observed several fault code #107 (isolation dsp cbit failure shut down fault) logged in the iabp log files.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.However, it was observed that the safety disk and tidal disk were due for replacement.Suggestions to the customer have been made to replace both items and a supplemental report will be submitted if additional information is provided.The status of the iabp unit is unknown.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10.The getinge field service engineer (fse) that had evaluated the iabp as mentioned in the initial emdr reported that the front end board is to be replaced, and that a quote was sent to customer.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Customer has not requested for service, po not provided.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 12564967
• MDR Text Key: 280942976
• Report Number: 2249723-2021-02232
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1