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

Model Number 0998-UC-3023-83

Device Problem Failure to Sense (1559)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Device not accessible for testing: (4117/3233): at this time, the customer has cancelled the service request and indicated that the iabp unit involved in this event is working fine and that the event had been caused due to user error.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter is (b)(6).Not returned to manufacturer.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) could not obtain the ecg tracing.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, g8, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d1, g1(contact person), h6(clinical code).

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,UTS,DOM
• 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: 12449426
• MDR Text Key: 270832570
• Report Number: 2249723-2021-02037
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108711
• UDI-Public: 10607567108711
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

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: Other
• Device Model Number: 0998-UC-3023-83
• Device Catalogue Number: 0998-UC-3023-83
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose