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

Model Number 0998-00-3023-65

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during an in-hospital inspection performed by the customer, the cs300 intra-aortic balloon pump (iabp) augmentation pressure led does not light up on the touch panel and an abnormal noise occurred from inside the crm.There was no patient use.

Manufacturer Narrative

Updated field: h6(type of investigation, investigation findings, component codes, investigation conclusions).Additional contact details: event site postal code: (b)(6), event site state: (b)(6).It was being reported that the cs300 intra aortic balloon pump (iabp) had an issue regarding the "augmentation pressure" of the led which does not light up.Also, there is an unusual noise coming up from inside the crm.A getinge field service engineer (fse) was being dispatched in order to evaluate the unit and during the evaluation it was being found that there is an augmentation led lighting failure on touch panel from which the abnormal noise is coming from inside the crm.There is also the deterioration or malfunction of the keypad controller board inside the touch panel which was affecting the lighting of the augmentation led.Even there is also an abnormal noise which was being generated due to deterioration of the fan inside the crm that removes water at the catheter insertion port.Fse had also replaced the assy crm japanese , pcb, keypad controller and after the replacement both the incidents were being resolved.No problems were being found during the operational inspection and the equipment is in good condition.There was no involvement of the patient.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• 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: 18887510
• MDR Text Key: 337474370
• Report Number: 2249723-2024-01050
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: 10607567108322
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1