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

Model Number	0998-00-3013-65
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1 site name : date medical services co., ltd.Shiga branch.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during customer inspection in progress by customer, the cs100 intra-aortic balloon pump (iabp) unit's cart caster is broken.There was no patient involvement.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: e1: (event site postal code: (b)(6)).It was reported that during inspection, the cs100 intra aortic balloon pump (iabp) cart caster broken.No patient involvement.A getinge field service engineer (fse) replaced the one front (recorder side) caster.Driving operation tested good.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the unit for the reported malfunction.The fse replaced the caster (0401-00-0062).A driving operation test was performed.Testing was good.The failure analysis and testing(fat) dept.Performed a visual inspection and found the caster broken and in pieces.The fat dept.Verified the complaint of a broken cart caster.Retaining the caster in the fat dept.Per procedure (b)(6) rev.Ar.
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. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 19446968
• Report Number: 2249723-2024-02279
• Device Sequence Number: 11573117
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684(21)SA06600-E7
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/25/2024

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: Health Professional
• Device Model Number: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 07/25/2024; 10/23/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/05/2024; 07/25/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2007
• 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.
• Patient Sex: Unknown