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

Model Number 0998-00-3013-65

Device Problem Communication or Transmission Problem (2896)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cs100 intra-aortic balloon pump (iabp) external ap signal cannot be input.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Additional information: (b)(6).It was reported that the cs100 intra-aortic balloon pump (iabp) had a issue of external ap signal cannot be input.There was no patient involvement.A getinge field service engineer evaluated the unit and found external pressure signal cannot be input.Replaced due to deterioration of external signal connector.Driving test > good results.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.The failure analysis and testing dept.Received part number rev.K with a reported unit failure of the external pressure signal not being input.The fat installed the part into cs100 test fixture serial number (b)(6) and tested the part to factory specifications per the cs100 service manual part number 0070-00-0528-01 rev ad.External blood pressure and ecg signal were input with no issues.Fat could not confirm the reported failure in this part.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• 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: 17884753
• MDR Text Key: 325067525
• Report Number: 2249723-2023-04356
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: 10607567107684
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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
• Device Operator: Other
• Device Model Number: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1