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

Model Number 0998-00-3023-53

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) has a low battery.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Type of investigation not yet determined: (4118) additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.No information provided.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, e1(event site email), e2, e3, g2, g3, g6, g7, h2, h3, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10, h11 corrected fields: g1(contact person).A getinge field service engineer was dispatched to investigate the issue.First, the fse toggled off the toggle switch on the power supply.Then, the fse switched on the power supply and charged the unit overnight.The battery test was completed with 136+ minutes.Unit passed all calibration, functional, and safety tests per factory specifications.The unit was then returned to the customer and cleared for clinical use.

• Brand Name: CS300,ENGLISH,110V,DOMESTIC
• Type of Device: 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: 12847063
• MDR Text Key: 284182816
• Report Number: 2249723-2021-02665
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1