MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problem Power Problem (3010)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

The customer has been presented with the cost estimate to repair the iabp unit.Repairs are pending approval.A supplemental report will be submitted if additional information is provided.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) powered off after being disconnected from the ac outlet.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10, h11.Corrected fields: d1, h3.At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.A getinge field service engineer (fse) advised that the customer has purchased new equipment and the iabp unit involved in this event will be decommissioned.A supplemental report will be submitted upon completion of our investigation.H3 other text : device decommissioned.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, b6, b7, g4, g7, g8, h2, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: d5, g1 (contact person ¿ mfg site), h4.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 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: 12016463
• MDR Text Key: 256749158
• Report Number: 2249723-2021-01282
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

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: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 11/12/2021; 08/03/2022
• Supplement Dates FDA Received: 12/07/2021; 08/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.
• Patient Sex: Prefer Not To Disclose