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

Model Number	0998-00-3013-61
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information is provided.The full name of the event site was shortened due to field character limit; the full name is: (b)(6).
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a continuous beep.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d9(device avail for evaluation), g1(contact person), h6(clinical code).
Event or Problem Description
N/a.

• Brand Name: CS100,GERMAN,NON-UTS,INTL
• 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: 12844229
• Report Number: 2249723-2021-02701
• Device Sequence Number: 17231015
• Product Code: DSP
• UDI-Device Identifier: 10607567112671
• UDI-Public: 10607567112671
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 0998-00-3013-61
• Device Catalogue Number: 0998-00-3013-61
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown