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

Model Number N/A

Device Problem Moisture or Humidity Problem (2986)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.Getinge service was not requested in connection with this event.A supplemental report will be submitted if additional information is made available.

Event Description

It as reported that during use in a patient the end user noticed ¿excessive¿ condensation in helium tubing on the cs300 intra-aortic balloon pump (iabp).There was no harm or injury to patient and no adverse event was reported.

Manufacturer Narrative

The customer reported that the iabp was pulled from service and a complete evaluation and pm was performed to factory specification.Additionally the iabp was opened and inspected for condensation and the safety disk was replaced.The customer indicted that the water condensation procedure was followed as per operation manual.The iabp remained in the biomed shop running overnight.The iabp was returned cleared for clinical service.

Event Description

It as reported that during use in a patient the end user noticed ¿excessive¿ condensation in helium tubing on the cs300 intra-aortic balloon pump (iabp).There was no harm or injury to patient 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: 8562355
• MDR Text Key: 143858222
• Report Number: 2249723-2019-00696
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 04/06/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 86