MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-61
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed that the 24v voltage collapses when the unit turns on.The fse determined that the unit could no longer be repaired and has to be shut down and scrapped.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) would no longer power on.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
Updated fields: b4, g4, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11 corrected fields: b6, b7, d1, d4(model#), d11, g1(contact person).
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V
• 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: 12389450
• Report Number: 2249723-2021-01958
• Device Sequence Number: 3577157
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose