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

Model Number 0998-00-0800-55

Device Problem Failure to Charge (1085)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

No service order report available yet.A supplemental report will be submitted when this information is provided to us.(b)(6).

Event Description

It was reported by the customer's biomed that before use, the batteries in the cardiosave intra-aortic balloon pump (iabp) are no longer charging and they are no longer recognized in either slot 1 or slot 2.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

It was reported that a battery was sent to the customer and the battery was replaced by the customer's biomedical engineer; subsequently the unit was cleared for clinical use.H3 other text : not returned to manufacturer.

Event Description

It was reported by the customer's biomed that before use, the batteries in the cardiosave intra-aortic balloon pump (iabp) are no longer charging and they are no longer recognized in either slot 1 or slot 2.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields; b4, b6, b7, d4, g3, g6, g7, h2, h6, h10, h11.Corrected fields; h4.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• 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: 11715862
• MDR Text Key: 247026174
• Report Number: 2249723-2021-00855
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2023

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: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 04/23/2021; 01/03/2023
• Supplement Dates FDA Received: 05/18/2021; 01/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose