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

Model Number 0998-00-3023-53

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer informed us that the customer was able to reproduce the problem using a trainer and another balloon.A video of the incorrect balloon waveform (blue waveform) has been attached to this complaint.In addition, the customer performed the calibrations and the device has been put back in use for now.A supplemental report will be submitted upon completion of this investigation.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp), when using 1:1 setting, the balloon waveform was squared off and did not look normal.When the setting was changed to 1:2, the balloon waveform looked normal.The customer replaced the unit with a different cs300 and continue with the therapy.There was no harm or injury to the patient and no adverse event was reported.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp), when using 1:1 setting, the balloon waveform was squared off and did not look normal.When the setting was changed to 1:2, the balloon waveform looked normal.The customer replaced the unit with a different cs300 and continue with the therapy.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

Customer reported that the iabp was repaired by disassembling the iabp and found one of the gaskets had dried out and cracked.Customer installed the 5000 hour pm kit and completed a full pm.It was reported that everything has ben working properly since then.Iabp has been back in service.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d4 (version or model #), g4, g7, g8, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: d1, g1, (contact person ¿ mfg site).

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11382866
• MDR Text Key: 233758758
• Report Number: 2249723-2021-00455
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1