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

Model Number UNKNOWN

Device Problems Inflation Problem (1310); Failure to Sense (1559); Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested, and we will report accordingly if it becomes available.Not returned to manufacturer.

Event Description

It was reported that during use on a patient requiring cardiopulmonary resuscitation in an emergency case, an intra-aortic balloon (iab) catheter was placed femorally in the target position.The patient¿s signal was taken from external signal source (ecg and arterial pressure) and fiber-optic sensor (arterial pressure).After the intra-artic balloon (iab) was placed in the target position, the start button was pressed on the unknown datascope intra-artic balloon pump (iabp); however, error messages such as inflation failure (high pressure) were displayed on the monitor and a ¿fiber-optic sensor failure¿ alarm was also generated.The iabp would not start.Both the iabp and iab were replaced by non-datascope devices and therapy was initiated.No patient harm, serious injury or adverse event was reported.This report is for the unknown datascope iabp used in the reported event.A separate report is being submitted for the iab catheter used in this event.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12101422
• MDR Text Key: 265580861
• Report Number: 2249723-2021-01412
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose