MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-55

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/31/2021

Event Type  malfunction  

Event Description

It was reported that the helium pressure is off on the cs300 intra-aortic balloon pump (iabp) monitor.It is unknown under which circumstances this occurred or if a patient was involved.However, no adverse event was reported.

Manufacturer Narrative

Type of investigation not yet determined.A supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported during a routine start-up check the cs300 intra-aortic balloon pump (iabp) monitor helium pressure is off.There was no patient involved.

Manufacturer Narrative

Updated sections: b4, e2, e3, g2, g3, g6, h2, h10, h11.Corrected sections: b5, b6, b7, d5, d10, h6(health clinical).

Manufacturer Narrative

At this time, the customer has decided not to pursue the repair as this device is no longer supported locally.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: 13316204
• MDR Text Key: 286657184
• Report Number: 2249723-2022-00136
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Device Lot Number: N/A NOT REQUIRED FOR HARDWARE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2021
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 10/05/2022; 03/21/2023
• Supplement Dates FDA Received: 12/01/2022; 03/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2007
• Type of Device Usage: Reuse
• Patient Sequence Number: 1