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 Material Deformation (2976)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined: the defective power supply was requested to be returned to the national repair center for further investigation.A supplemental report will be submitted when our investigation is completed.The initial reporter is a getinge authorized representative who has different contact details from that of the event site.A contact telephone number at the event site is (b)(6).

Event Description

It was reported that during a service repair (mfg report number 2249723-2021-01949) performed by a getinge authorized distributor's field service engineer (fse), in an attempt to installed a new power supply, when the fse removed the new power supply sn#(b)(4) from the packaging, it was realized that the chassis/enclosure of the power supply was bent and it had a loose rivet.This is a failure during an installation.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge authorized distributor's field service engineer (fse) in relation to a separate and unrelated issue, the fse attempted to install a new power supply.However, when the fse removed the new power supply from its packaging, he found the chassis enclosure of the power supply was found bent and had a loose rivet.This is a failure during an installation.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, d9, g2, g3, g6, g7, h2, h3, h4, h6, h10, h11 corrected fields: b5, d1, d4, e1.A getinge authorized distributor's field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The iabp needed a power supply replacement due to faulty fan.In an attempt to install a new power supply, the fse noted that the chassis/enclosure of the new power supply was bent and it had a loose rivet.The iabp was then taken to the fse's facility to await repair.The fse replaced and installed a new power supply in the iabp to resolve the issue.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp was then released to the customer and cleared for clinical service.

• 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: 12424784
• MDR Text Key: 269864333
• Report Number: 2249723-2021-02013
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• 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
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1