MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Device Damaged Prior to Use (2284); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that during a fiber optic test of the cs300 intra-aortic balloon pump (iabp), a dsp hardware error alarm occurred.This event occurred during operation testing before shipment, and is therefore an out of box failure (oob).There was no patient involvement; thus no adverse event was reported.

Manufacturer Narrative

The getinge fse evaluated the iabp unit and replaced the fiber optical assembly.The fse performed running test without experiencing and problems and the iabp was cleared for clinical use.The faulty fiber optic assembly was returned to the getinge national repair center (nrc) for further evaluation.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that during a fiber optic test of the cs300 intra-aortic balloon pump (iabp), a dsp hardware error alarm occurred.This event occurred during operation testing before shipment, and is therefore an out of box failure (oob).There was no patient involvement; thus no adverse event was reported.

Manufacturer Narrative

The fiber optic sensor assembly was received by the getinge national repair center (nrc) for further investigation of the out of box failure.A senior repair technician of the nrc inspected the fiber optic sensor assembly and no visual damage was observed.The technician installed the fiber optic sensor assembly into a cs300 test fixture and tested to factory specifications per cs300 service manual.Testing passed and the technician could not verify the reported failure "during the fiber optic test, dsp hardware error alarm occurred".A capa was previously initiated as a response regarding cracked vias on the fiber optic interface board below revision e, which could cause intermittent dsp hardware error.The nrc replaced fiber optic interface board rev d.With a board rev e.The board was installed into the fiber optic sensor assembly, and tested in the cs300 test fixture to factory specifications per cs300 service manual.The technician inspected the fiber optic sensor assembly per procedure.Testing passed and fiber optic assembly was put into stock per procedure.

Event Description

It was reported that during a fiber optic test of the cs300 intra-aortic balloon pump (iabp), a dsp hardware error alarm occurred.This event occurred during operation testing before shipment, and is therefore an out of box failure (oob).There was no patient involvement; thus no adverse event was reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7707556
• MDR Text Key: 114826269
• Report Number: 2249723-2018-01226
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1