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

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/01/2021

Event Type  malfunction  

Event Description

It was reported that prior to use, while changing out the helium tank, the cardiosave intra-aortic balloon pump (iabp) gas tank read as empty upon initial installation.The tank was then exchanged for another one and it read as full.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A supplemental report will be submitted upon receipt of additional information or completion of our investigation.H3 other text : no service requested.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, e1 (site country), g3, g6, h2, h6 (type of investigation, investigation findings and investigation conclusions), h10, h11 corrected field: d1, d5 additional contact information: (b)(6) customer was just replacing the helium tank on the cardiosave unit because it was low.They opened a new tank out of the box and removed the plastic shrink wrap peal from the tank.Inserted the new tank into the machine and the helium indicator showed that the new tank was empty.They then proceeded to open another new tank.Removed the plastic shrink wrap and inserted the tank into the machine.Machine showed that the second new tank was full.There was nothing wrong with the cardiosave pump.

• Brand Name: UNKNOWN
• 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: 12698448
• MDR Text Key: 282123195
• Report Number: 2249723-2021-02458
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1