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

Model Number N/A

Device Problems No Display/Image (1183); Failure to Pump (1502); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) has advised that the iabp is undergoing testing, but the repair has not yet started because the source of the problem has not yet been found.Also, the fse has reported that the customer may decide not to repair unit do to age of the pump.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) stopped pumping and the screen went black.There was no alarm.The iabp did restart but was replaced.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) has advised that the iabp is permanently out of service.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) stopped pumping and the screen went black.There was no alarm.The iabp did restart but was replaced.No patient harm, serious injury or adverse event was reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10478654
• MDR Text Key: 205261433
• Report Number: 2249723-2020-01402
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 75