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 Problems Inability to Auto-Fill (1044); Suction Problem (2170)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: during a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered that the unit was only producing 140 mmhg of vacuum during check, unit should produce a minimum of 125 mmhg of vacuum.Trying to fix the issue, the fse installed a 2,500 hour maintenance kit that the customer provided with no change in vacuum.He replaced the worn pressure hose in compressor compartment during this installation.Also, during inspection of vacuum side pump head on the compressor, discovered the reed valve was loose and the screw would not tighten the reed valve down, so replaced the vacuum side head on compressor and now the unit creates the correct amount of vacuum.Unit passed all functional, safety, and electrical tests to factory specifications.Unit is cleared for clinical use and returned to customer.A supplemental report will be submitted upon completion of our investigation.(b)(6).The initial reporter is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), discovered unit had poor vacuum.Unit failed vacuum check with a reading of 150 mmhg, when the reading should be 125 to 0 mmhg.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d1, g1(contact person), h6(problem code & component codes).

• 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: 12291305
• MDR Text Key: 265581542
• Report Number: 2249723-2021-01715
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1