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

Model Number	N/A
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
It was reported that the cardiosave battery charging station needs to be returned because is difficult for the customer to remove the battery pack from one of the slots.Since this is an accessory for the iabp, there was no patient involvement.
Additional Manufacturer Narrative
Corrected fields: (health effect ¿ clinical code).
Event or Problem Description
It was reported that the cardiosave battery charging station needs to be returned because is difficult for the customer to remove the battery pack from one of the slots.Since this is an accessory for the iabp, there was no patient involvement.
Additional Manufacturer Narrative
Updated fields: e1 (site country), h6 (type of investigation, investigation findings and investigation conclusions).Additional contact information: (b)(6).Gfe attempts were performed to obtain additional information and no response was provided.If no response is provided, the complaint will be closed and, if new information and/or devices are available, the file will be reopened and updated.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11381772
• Report Number: 2249723-2021-00426
• Device Sequence Number: 14475299
• Product Code: DSP
• UDI-Device Identifier: 10607567111964
• UDI-Public: 10607567111964
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0802
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/01/2021; 04/08/2024
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/23/2021; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown