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

Model Number N/A

Device Problem Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per sop since the serial number for the unit was not provided.At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.A supplemental report will be submitted if additional information is provided.

Event Description

During use on a patient, the arterial pressure waveform for the cs300 intra-aortic balloon pump (iabp) appeared unstable.Subsequently, the arterial pressure waveform has become stable and the patient had been reported in stable condition under iabp therapy.No patient harm or adverse event was reported.

Manufacturer Narrative

On january 28, 2020, further review of this complaint event was conducted, and it was determined that an initial emdr for this complaint was incorrectly submitted.The reason no emdr was required is because there was never an alleged malfunction of the iabp.In addition, a getinge representative has advised that no anomalies were noted with the iabp unit involved in this event.The iabp unit remains in clinical use and no issues have been reported.Please refer to mfg report number 2248146-2019-00935 submitted on the intra-aortic balloon for relevant information on this complaint event.Please note that this complaint will be cancelled in our database.

Event Description

During use on a patient, the arterial pressure waveform for the cs300 intra-aortic balloon pump (iabp) appeared unstable.Subsequently, the arterial pressure waveform has become stable and the patient had been reported in stable condition under iabp therapy.No patient harm or adverse event was reported.On january 28, 2020, further review of this complaint event was conducted, and it was determined that an initial emdr for this complaint was incorrectly submitted.The reason no emdr was required is because there was never an alleged malfunction of the iabp.In addition, a getinge representative has advised that no anomalies were noted with the iabp unit involved in this event.The iabp unit remains in clinical use and no issues have been reported.Please refer to mfg report number 2248146-2019-00935 submitted on the intra-aortic balloon for relevant information on this complaint event.Please note that this complaint will be cancelled in our database.

• 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: 9491495
• MDR Text Key: 191407380
• Report Number: 2249723-2019-02065
• 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: 02/07/2020

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: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1