MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-65
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during an inspection the cs100 intra-aortic balloon pump (iabp) unit had abnormal noise due to fan abnormality.There was no patient harm reported.
Event or Problem Description
It was reported that during preventative maintenance by getinge field service engineer, the cs100 intra-aortic balloon pump (iabp) unit had abnormal noise due to fan abnormality.There was no patient involvement.
Additional Manufacturer Narrative
The fse that encountered the issue replaced the power supply (0014-00-0033-05).The inspection results were good.Iabp was returned to customer.
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18057448
• Report Number: 2249723-2023-04702
• Device Sequence Number: 12505480
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684(21)SA157256D9
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2024

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: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 11/29/2023; 02/13/2024; 09/25/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/01/2023; 02/15/2024; 09/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2009
• 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: N/A.; UNKNOWN.
• Patient Sex: Unknown