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

Model Number 0998-00-0800-65

Device Problem Structural Problem (2506)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had rivets in the cart that were found to fall off.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

Type of investigation not yet determined: a supplemental report will be submitted upon receipt of additional information.

Manufacturer Narrative

Updated fields - b4,d5,e1(site country,event site state - (b)(6), event site postal code - (b)(6)),e2,e3,g3,g6,h2,h4,h6(type of investigation,investigation findings,investigation conclusions),h10.Corrected fields - b5,h6(health effect ¿ clinical code).A getinge field service engineer (fse) stated, rivets in the cart were found to fall off.Its unknown if the issue has been resolved but the complaint may be reopened in future if the response is received.

Event Description

It was reported during pre-delivery inspection that the cardiosave intra-aortic balloon pump (iabp) had rivets in the cart that were found to fall off.No patient involvement.

• Brand Name: CARDIOSAVE HYBRID
• 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: 14489569
• MDR Text Key: 292602264
• Report Number: 2249723-2022-01217
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2024

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?: No
• Device Operator: Other
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 06/14/2024
• Supplement Dates FDA Received: 06/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1