MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Failure to Charge (1085)

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

Event Type  malfunction  

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) had no 220v ac power and the batteries that will not charge.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Additional information is being requested in regards to whether or not the customer has requested for getinge to service the iabp unit involved.A supplemental report will be submitted when additional information is provided.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10, h11 corrected fields: d10, h2, h6 (type of investigation, component codes) testing of actual/suspected device (10/3233): a getinge field service engineer (fse) evaluated the iabp unit for the reported "batteries will not charge", to fix the issue the fse replaced the power supply, and then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during a routine check it was observed that the cs100 intra-aortic balloon pump (iabp) had no 220v ac power and the batteries that will not charge.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: g1 (contact person ¿ mfg site).

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: 12758965
• MDR Text Key: 281742193
• Report Number: 2249723-2021-02563
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2022

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
• Device Operator: Other
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/17/2021; 03/14/2022; 09/15/2022
• Supplement Dates FDA Received: 12/10/2021; 04/08/2022; 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1