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

Model Number	0998-00-3013-68
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted as the result of a retrospective review conducted in capa (b)(4).A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), it was observed that the doppler on the cs100 intra-aortic balloon pump (iabp) had the latch on the access door broken.There was no patient involvement.
Additional Manufacturer Narrative
It was reported that the cs100 intra-aortic balloon pump (iabp) doppler.Getinge field service engineer (fse) it was observed that the doppler and had the latch on the access door broken.During preventative maintenance, the need to replace the batteries and the security disk was found broken.Doppler access door latch (d366-00-0113) was replaced.During pm the battery sealed lead acid 12v(0146-00-0039),safety disk (0997-00-0985-08), knob door latch (0366-00-0113), screw pan head (0212-12-0408), bracket pole mtg iabp (0406-00-0742), pim component (0103-00-0398-01), knob release (0367-00-0076) was replaced.There was no patient involvement.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: 16263494
• Report Number: 2249723-2023-00655
• Device Sequence Number: 4173811
• Product Code: DSP
• UDI-Device Identifier: 10607567107691
• UDI-Public: 10607567107691
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: Other
• Device Model Number: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2005
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown