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

Catalog Number	0998-UC-3013-65
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon receipt of additional information.(b)(6).
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) display blacked out.After starting back up, the display became distorted and could not be used.No patient harm, serious injury or adverse event was reported.
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) display blacked out.After starting back up, the display became distorted and could not be used.No patient harm, serious injury or adverse event was reported.
Additional Manufacturer Narrative
This iabp unit is a gettinge fixed asset and was being used as a replacement at the customer's facility.Thus, this iabp unit will not be returned to the facility after completion of the repair.It is unknown as to when the repairs will be completed.If any pertinent information is received in the future, a supplemental report will be submitted.

• Brand Name: CS100
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11072204
• Report Number: 2249723-2020-02238
• Device Sequence Number: 3207194
• Product Code: DSP
• UDI-Device Identifier: 10607567108674
• UDI-Public: 10607567108674
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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 Catalogue Number: 0998-UC-3013-65
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1