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

Model Number	0998-00-3023-83
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing of actual/suspected device: (10 & 4105/213): a getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.The fse cleaned and reseated the color display to video cable, tested and observed no ¿artifact on power¿ up.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
Event or Problem Description
It was reported that during power up test performed by the customer, the cs300 intra-aortic balloon pump (iabp) had white lines appear across the screen.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, d8, g3, g6, g7, h2, h5, h6, h10, h11.Corrected fields: d1, e1, g1, h4, h6 (medical device ¿ problem code).Additional email address: accountspayable@licommunityhospital.Org.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12049317
• Report Number: 2249723-2021-01328
• Device Sequence Number: 19699108
• Product Code: DSP
• UDI-Device Identifier: 10607567108285
• UDI-Public: 10607567108285
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: Health Professional
• Device Model Number: 0998-00-3023-83
• Device Catalogue Number: 0998-00-3023-83
• Device Lot Number: N/A
• 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: 05/27/2021
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.; UNKNOWN.
• Patient Sex: Unknown