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

Catalog Number 0998-00-3023-53

Device Problem Power Problem (3010)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) visited the customer's site, and observed an issue with the power supply/ charger assembly of the iabp unit.Estimates of the repairs were submitted to the customer.A supplemental report will be submitted when additional information is provided.(b)(6).

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) would not function on ac power.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Updated fields: a1, a3(to be left blank), b4, b5, e1(event site email), e2, e3, g3, g4, g7, h2, h6(patient codes), h10.

Event Description

It was reported that during a routine check, the cs300 intra-aortic balloon pump (iabp) would not function on ac power.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) that had evaluated the iabp and submitted an estimate of the repairs to the customer as mentioned in the initial mdr, reported that the customer has confirmed via telephone that the power supply charger issue was repaired by themselves.It was also reported that the customer denied to share the repaired part details with the fse; however, in a resent visit to the customer done by the fse, the iabp was checked and all functional tests were performed, and found the iabp working satisfactory.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during a routine check, the cs300 intra-aortic balloon pump (iabp) would not function on ac power.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h4, h6 (type of investigation), h10, h11.Corrected field: d4 (serial#).

Event Description

N/a.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10898196
• MDR Text Key: 218252643
• Report Number: 2249723-2020-02008
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1