MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-45

Device Problem Gas/Air Leak (2946)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.E1 event site telephone: the complete number is (b)(6).

Event Description

It was reported that during the testing process, the cs100 intra-aortic balloon pump (iabp).Had an air leakage.There was no harm reported.

Event Description

It was reported that during the testing process, the cs100 intra-aortic balloon pump (iabp) had an air leakage.There was no patient involvement.

Manufacturer Narrative

Additional information: event site postal code: (b)(6).A getinge field service engineer (fse) was being dispatched in order to evaluate the unit and it was being determined that the safety plate was leaking and it needed to be replaced however the fse is still in the process to negotiate with the hospital regarding the repair.The repair has not been carried out yet.If any pertinent information is received in the future, a supplemental report will be submitted.H3 other text: device evaluated however repair pending.

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 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.; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 18912640
• MDR Text Key: 337762156
• Report Number: 2249723-2024-01093
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: 10607567107790
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2024

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: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 07/16/2024
• Supplement Dates FDA Received: 03/20/2024; 07/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1