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

Model Number 0998-00-3023-55

Device Problem Pressure Problem (3012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse inspected the iabp and found the pressure transducer had failed causing the iabp to alarm.The fse inspected the event log and found electrical test code # 52.The fse replaced the pressure transducer and calibrated it.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had a high drive pressure alarm.No patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) generated a high drive pressure alarm and displayed maintenance required code #2.There was no patient harm, serious injury or adverse event reported.

Manufacturer Narrative

Analysis of production: (3331/102) the device history records 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.Trend analysis: (4110/102) the overall 12 month product complaint trend data for the period feb 2020 through jan 2021 was reviewed.There were no triggers identified for the review period.Historical data analysis: (4109/102) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11382687
• MDR Text Key: 233751174
• Report Number: 2249723-2021-00444
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• 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
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1