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

Model Number	0998-UC-3013-61
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted if subsequent information is provided.Device not returned to manufacturer.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) would not switch on.There was no patient involvement, and no adverse event reported.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) would not switch on.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
A getinge field service reported that there was no repair performed.The fse stated the main switch was not switched on and the caused the unit not to start.Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation), (investigation findings), (component codes), (health effects-impact codes), (investigation conclusion).Corrected fields: h6 (health effect- clinical codes).
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, GERMAN,NON-UTS,INTL
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11095552
• Report Number: 2249723-2020-02241
• Device Sequence Number: 16355392
• Product Code: DSP
• UDI-Device Identifier: 10607567108650
• UDI-Public: 10607567108650
• 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,Followup
• Report Date (Section B): 11/15/2022

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-UC-3013-61
• Device Catalogue Number: 0998-UC-3013-61
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 05/18/2021; 11/17/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 06/11/2021; 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2002
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown