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	06/17/2024
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 customer inspection, the cs100 intra-aortic balloon pump (iabp) unit's two rear cart casters are broken.There was no patients involved.
Additional Manufacturer Narrative
Updated fields; b4, d9, g3, g6, h2, h3, h4, h6 ,h11.Corrected fields; d4(udi).A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that they replaced the casters.The unit passed all functional and safety tests.The following was performed by a sr service technician of the maquet failure analysis and testing dept.Wayne, nj ab.The failure analysis and testing department received caster qty2 , with a reported unit failure of two rear cart casters are broken.The fat department performed a visual inspection of the parts received and found that all received casters are broken.Due to the broken casters, it cannot be installed and investigated any further.The failure analysis and testing department verified the failure of the broken casters.Retaining the casters in the fat department per procedure.The potential root cause for this failure is covered under cs100-cs300 hazard analysis.The potential cause of failure is mechanical - device transport failure.
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: 19679709
• Report Number: 2249723-2024-02728
• Device Sequence Number: 3166186
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684(21)SA06765-G7
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 06/17/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 11/22/2024
• 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