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 Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.Error codes #111 and #112 were recorded in the fault logs.The fse replaced the executive processor board, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that at the time of inspection, the cardiosave intra-aortic balloon pump (iabp) had an internal communication error while the unit was running and was on standby.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The executive processor board was replaced as a precautionary measure.

Event Description

It was reported that at the time of inspection, the cardiosave intra-aortic balloon pump (iabp) had an internal communication error while the unit was running and was on standby.There was no patient involvement and no adverse event reported.

Manufacturer Narrative

The inspection of the exch pcb, exec processor was performed by technician of the maquet national repair center (nrc) per procedure.The nrc installed the board into the cardiosave test fixture and tested the board to factory specifications per procedure and the cardiosave service manual.The board passed testing and was then returned to supplier.Board was received back from supplier and investigation was performed by another technician of the maquet nrc.The supplier could not verify the failure of internal communication error.The board passed testing.Inspection of the board was completed per procedure with no visual damage observed.The nrc installed the board into the cardiosave test fixture and tested the board to factory specifications per procedure and the cardiosave service manual.The board passed testing.Nrc will retain the board per procedure.

• 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 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11334345
• MDR Text Key: 232339391
• Report Number: 2249723-2021-00299
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1