MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the blood pressure reading was much higher than other sources.Aortic pressure and cuff pressure were matched with the balloon off, but the intra-aortic balloon pump (iabp) read 50-60 points higher.The patient was transferred with receiving facilities pump and no other issues were noted.No adverse event, patient injury or death was reported.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the blood pressure reading was much higher than other sources.Aortic pressure and cuff pressure were matched with the balloon off, but the intra-aortic balloon pump (iabp) read 50-60 points higher.The patient was transferred with receiving facilities pump and no other issues were noted.No adverse event, patient injury or death was reported.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8408804
• MDR Text Key: 138551432
• Report Number: 2248146-2019-00194
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• 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: 04/04/2019

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 Catalogue Number: 0684-00-0567
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 64