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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The stm noted that the power switch had been turned off causing the iabp unit to not charge the battery.The stm turned the switch on and verified proper charging, then vacuumed the power supply and fan to eliminate the maintenance code #7.Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).

Event Description

It was reported that during preventative maintenance (pm) performed by a getinge service territory manager (stm), the cs300 intra-aortic balloon pump (iabp) generated a "maintenance required code#7." there was no patient involved and no adverse event was reported.

Event Description

It was reported that during preventative maintenance (pm) performed by a getinge service territory manager (stm), the cs300 intra-aortic balloon pump (iabp) generated a "maintenance required code#7." there was no patient involved and no 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: 10478656
• MDR Text Key: 205260431
• Report Number: 2249723-2020-01403
• 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
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1