MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-62
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.The fse removed the monitor and rebuilt the contacts.The iabp cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that on start-up the cs300 intra-aortic balloon pump (iabp) display had green lines making the data unreadable.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11 corrected fields: d1, g1(contact person), h4.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V
• Common Device Name: 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12172294
• Report Number: 2249723-2021-01527
• Device Sequence Number: 11170766
• Product Code: DSP
• UDI-Device Identifier: 10607567108292
• UDI-Public: 10607567108292
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 0998-00-3023-62
• Device Catalogue Number: 0998-00-3023-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown