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

Model Number N/A

Device Problem Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.(b)(6).

Event Description

The customer reported that while in use on a patient, the cs300 intra-aortic balloon pump (iabp) was noticed to have a smell of burning condenser from the fan of the power unit.The iabp was continuously used.Furthermore, no patient harm or serious injury was reported, and there was no adverse event reported.

Manufacturer Narrative

A field service engineer (fse) evaluated the iabp and was able to reproduce the reported issue.It was confirmed that the abnormal odor from fan was due to battery deterioration.The battery was overcharged, due to the customer not replacing them.The water in the battery boiled, steam was belched, and abnormal odor was generated.To fix the issue, the fse replaced the battery and safety disk.The fse then performed running tests without any problem occurring.The iabp was then released to the customer and cleared for clinical service.

Event Description

The customer reported that while in use on a patient, the cs300 intra-aortic balloon pump (iabp) was noticed to have a smell of burning condenser from the fan of the power unit.The iabp was continuously used.Furthermore, no patient harm or serious injury was reported, and there was no adverse event reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7259894
• MDR Text Key: 99998448
• Report Number: 2249723-2018-00220
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

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: N/A
• Device Catalogue Number: 0998-00-3023-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1