MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-69
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The getinge field service engineer (fse) performing the field corrective action observed that the battery only charged for 61 minutes instead of the minimum 135 minutes.To resolve the issue the fse has ordered a battery for replacement.The unit has not been cleared for clinical use pending battery replacement.A supplemental report will be submitted if additional information is provided.The full name is (b)(6).
Event or Problem Description
It was reported that during a field corrective action, the cs100 intra-aortic balloon pump (iabp) failed the battery run time test.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
It was reported that the iabp has not been released for use and is unknown when this unit will be serviced and returned to the customer for clinical use.A supplemental report will be submitted if additional information is provided.
Event or Problem Description
It was reported that during a field corrective action, the cs100 intra-aortic balloon pump (iabp) failed the battery run time test.There was no patient involvement, and no adverse event reported.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V
• 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: 10796102
• Report Number: 2249723-2020-01835
• Device Sequence Number: 17063951
• Product Code: DSP
• UDI-Device Identifier: 10607567108698
• UDI-Public: 10607567108698
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

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: Other
• Device Model Number: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 01/26/2021; 11/28/2022
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 02/19/2021; 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2014
• 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