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 Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp.Additional information was requested from the customer with regard to the repair and status of the iabp; however, despite our best efforts, no repair information and no status of the iabp has been received.If any pertinent information is received in the future, a supplemental report will be submitted.Patient height: 5"6'.Not returned to manufacturer.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) displayed "no cable" under "pressure source".A fiberoptic catheter was connected to the iabp and was transmitting correctly.There was no other cable connected to the iabp.The iabp was taken to their biomed when the therapy finished.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, b6, b7, d10, g3, g6, g7, h2, h6(investigation type, component codes & impact codes), h10, h11 corrected fields: b5, d1, d4(model#), g1(contact person), h4, h6(clinical code).

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) displayed "no cable" under "pressure source".A fiberoptic catheter was connected to the iabp and was transmitting correctly.There was no other cable connected to the iabp.The iabp was taken to their biomed when the therapy finished.

• 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: 11281231
• MDR Text Key: 230729734
• Report Number: 2249723-2021-00209
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2007
• 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
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 96 KG