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

Model Number 0998-UC-3013-53

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.Upon switching the unit on, the unit showed "low battery message." further testing revealed that the on/off switch on the power supply was in off position.After switching the power supply to on, the battery began to charge and the low battery message disappeared.The fse observed the unit with a trainer and balloon connected and the unit worked fine.The fse recommended that the customer should keep the unit charging.The fse then performed a full pm with calibration, functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6).

Event Description

It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) was not working.No patient harm, serious injury or adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

Analysis of production: (3331) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr 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 (may 2019 through apr 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
• MDR Report Key: 11822043
• MDR Text Key: 251198558
• Report Number: 2249723-2021-01009
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107745
• UDI-Public: 10607567107745
• 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
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-UC-3013-53
• Device Catalogue Number: 0998-UC-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2021
• Patient Sequence Number: 1
• Treatment: LINEAR.