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

Model Number N/A

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

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 supplemental report will be submitted when additional information is provided.Full event site name: (b)(6).

Event Description

It was reported that during use on a patient the cs300 intra-aortic balloon pump (iabp) the counter-pulse pressure adjustment indicator in the control panel of the iabp device did not light.There is a problem with the keyboard control board.The iabp was newly installed on (b)(6) 2020, and was used for the first time on (b)(6) 2020.There was no harm or injury to 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) the counter-pulse pressure adjustment indicator in the control panel of the iabp device did not light.There is a problem with the keyboard control board.The iabp was newly installed on may 19, 2020, and was used for the first time on june 9, 2020.There was no harm or injury to patient and no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) reported that the distributor engineer replaced the keypad control board.The iabp was cleared for clinical use.

• 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: 10219780
• MDR Text Key: 197294176
• Report Number: 2249723-2020-01006
• Device Sequence Number: 1
• Product Code: DSP
• 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: 08/24/2020

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: N/A
• Device Catalogue Number: 0998-00-3023-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/13/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1