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

Model Number N/A

Device Problem Circuit Failure (1089)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge representative has reported that the iabp unit was evaluated by a getinge field service engineer (fse) and the compressor and motor control board have been identified as defective.The repair is underway but not completed.A supplemental report will be submitted when additional information is provided.

Event Description

I was reported that during a routine check performed by the customer, the mains fuse for the cs100 intra-aortic balloon pump (iabp) was blowing.There was no patient involved; thus, no adverse event reported.

Event Description

I was reported that during a routine check performed by the customer, the mains fuse for the cs100 intra-aortic balloon pump (iabp) was blowing.There was no patient involved; thus, no adverse event reported.

Manufacturer Narrative

Initial reporter should have read (b)(6).The intra-aortic balloon pump(iabp) was evaluated by a getinge representative.The compressor assay and motor control board were replaced.All functional and safety tests were performed and passed to meet factory specifications.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8894330
• MDR Text Key: 186732644
• Report Number: 2249723-2019-01275
• Device Sequence Number: 1
• Product Code: DSP
• 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
• Report Date: 10/14/2019

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: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1