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	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.Not returned to manufacturer.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) gave an alarm and a message.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
Additional Manufacturer Narrative
Event site postal code- (b)(6).It was reported that the cs300 intra-aortic balloon pump (iabp) gave an alarm and a message.It was also unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.He couldn't give me the serial number.The alarm was triggered with the extension disconnection message as a fault.However, it seems that the extension is well connected.After a few manipulations, everything is back to normal but it needs to be recalled by an fse.The equipment was cleared for customer use.

• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13481363
• Report Number: 2249723-2022-00243
• Device Sequence Number: 14764356
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown