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

Model Number	0998-00-0800-35
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during daily inspection the cardiosave intra-aortic balloon pump (iabp) unit gas leaked out when opening cylinder helium tank cap.There was no patient harm reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
A getinge field service (fse) evaluated the unit for the reported malfunction.The fse noted that the unit was missing an o-ring.To correct the reported issue, the fse replaced the o-ring, and the unit then passed operational testing.The unit was then returned to the customer.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4,e1(name),e2,e3,g3,g6,h2,h10.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE M PLUG
• Common Device Name: 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: 17324566
• Report Number: 2249723-2023-03172
• Device Sequence Number: 20214627
• Product Code: DSP
• UDI-Device Identifier: 10607567109107
• UDI-Public: 10607567109107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0998-00-0800-35
• Device Catalogue Number: 0998-00-0800-35
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 10/28/2023; 11/22/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 11/01/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown