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

Catalog Number 0998-00-3013-53

Device Problem Charging Problem (2892)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested, and we will report accordingly if it becomes available.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) displayed low battery.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.

Event Description

It was reported that before use, the cs100 intra-aortic balloon pump (iabp) displayed low battery.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge authorized distributor's field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.After charging the iabp for 8 hours, the iabp still displayed low battery, so it was confirmed that the battery was abnormal after the test.An order to replaced the battery was made.It was also recommended to the customer not to use the iabp until the battery is replaced.If any pertinent information is received in the future, a supplemental report will be submitted.

Manufacturer Narrative

A getinge service representative reported that the getinge authorized distributor's field service engineer (fse) that evaluated the iabp has already replaced the battery , the iabp is operating normally, and it has been returned to the customer and cleared for clinical use.

Event Description

It was reported that before use, the cs100 intra-aortic balloon pump (iabp) displayed low battery.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/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: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) 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.

• 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: 11337264
• MDR Text Key: 232179515
• Report Number: 2249723-2021-00303
• 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,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0998-00-3013-53
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1