MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-58
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event site name is shortened due to field character limit.The full name is (b)(6).Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the batteries.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a battery change.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.Cambio de baterias.El cliente no aporta mas informacion cs300 **cesion.This is an automated draft translation - if any uncertainty contact the local ssu immediately: battery change * the client does not provide more information cs300 **assignment.
Event or Problem Description
It was reported that during a preliminary check-up the cs300 intra-aortic balloon pump (iabp) had a battery change.There was no patient involvement, and no adverse event was reported.
Additional Manufacturer Narrative
Corrected data : b-5, b-6, b-7, d-11.Additional data : b-4, g-4, g-7 , h-2, h-6, h-10, h-11.
Additional Manufacturer Narrative
It was reported that, during routine check the cs300 intra-aortic balloon pump (iabp) had an issue with battery.Client did not provide more information.A getinge field service engineer (fse) investigated the issue and replaced batteries (d040-00-0147).No patient was involved.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 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. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 14251739
• Report Number: 2249723-2022-00977
• Device Sequence Number: 20055515
• Product Code: DSP
• UDI-Device Identifier: 10607567108759
• UDI-Public: 10607567108759
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063525
• 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): 03/22/2024

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: Other
• Device Model Number: 0998-UC-3023-58
• Device Catalogue Number: 0998-UC-3023-58
• 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: 04/04/2022
• Supplement Date Received by Manufacturer: 05/14/2022; 02/27/2024
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/07/2022; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown