MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 06/27/2021

Event Type  malfunction  

Manufacturer Narrative

Device not returned: additional information has been requested, and we will report accordingly if it becomes available.

Event Description

It was reported that during a routine check the cs100 intra-aortic balloon pump (iabp) had an electrical test failure code #50.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6(component code), h10, h11.Corrected fields: d10, h6(type of investigation), h10.A getinge field service engineer (fse) evaluated the iabp unit and was able to observed the reported issue.Repairs are still pending, and awaiting payment from the customer.It is unknown as to when the customer will submit payment for the repairs to be completed.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h4, h6, h10.It is still unknown as to when the customer will submit payment for the repairs to be completed.A supplemental report will be submitted if this information is provided to us.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 aug 2019 through jul 2021 was reviewed.There were no triggers identified for the review period.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (type of investigation), (investigation findings), (investigation findings), h10.The customer has repaired the unit on their own.The unit is working properly.

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12248267
• MDR Text Key: 264491107
• Report Number: 2249723-2021-01646
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose