MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-53

Device Problem Pumping Stopped (1503)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluate the unit and reported that boot test takes less than 5 minutes to shutdown after replacing power supply, solenoid board, motor control board and cross test still can not improve the situation.The service was not completed.A supplemental report will be submitted when final service report becomes available.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) will automatically shut down, before 30 minutes of use.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.Original description: 2/1 dealer notification: failure reason: the device will automatically shut down after less than 30 minutes of use repair content: the boot test takes less than 5 minutes to shutdown.Replacing power supply, solenoid board, motor control board and cross test still can not improve the situation.After replacing the main board, test for 30 minutes to shut down the device and install the battery, and the device still automatically shuts down when it is turned on again.Awaiting follow-up test.Software version: front end: (b)(4).

Event Description

It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) will automatically shut down, before 30 minutes of use.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A quote was provided to the customer for the repair of the unit; however the customer has decided to scrap the unit.The unit was returned to the customer and will be scrapped.

Event Description

N/a.

Manufacturer Narrative

Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period mar 2019 through feb 2021 was reviewed.There were no triggers identified for the review period.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11373144
• MDR Text Key: 233326893
• Report Number: 2249723-2021-00371
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.