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

Model Number N/A

Device Problem Failure to Power Up (1476)

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

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) failed to power up.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.

Event Description

It was reported that during a routine check performed by the customer, the cs100 intra-aortic balloon pump (iabp) failed to power up.There was no patient involved and no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and suspected that the power supply was faulty.The fse indicated that the evaluation would need to be saved for further diagnosis and handed over the iabp unit as is.The fse then returned to the customer a few days later and confirmed that the power supply was indeed faulty.The fse replaced the power supply then completed all safety, functionality, and calibration checks.All tests passed to factory specifications and the iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that during a routine check performed by the customer, the cs100 intra-aortic balloon pump (iabp) failed to power up.There was no patient involved and no adverse event was reported.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• MDR Report Key: 11445781
• MDR Text Key: 240389877
• Report Number: 2249723-2021-00474
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/24/2021
• Patient Sequence Number: 1