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

Model Number	0998-00-3023-62
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The getinge field service engineer (fse) reported that the customer has not requested getinge to evaluate the iabp in connection with this event.However, we were advise that the customer's biomed tested the iabp unit on batteries and ac power and it was ok.(b)(6).
Event or Problem Description
It was reported by the customer's biomed that the cs300 intra-aortic balloon pump (iabp) was on batteries and when switched off, there was no ac power.Subsequently, the user switched on the ac power and after that the machine switched on directly.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
Event or Problem Description
It was reported by the customer's biomed that during use on a patient the cs300 intra-aortic balloon pump (iabp) was on batteries and when switched off, there was no ac power.Subsequently, the user switched off and on the ac power and after that the machine switched on directly.There was no harm or injury to patient and no adverse event was reported.
Additional Manufacturer Narrative
A getinge field service engineer (fse) reported that a preventive maintenance (pm) was performed, and that the batteries were checked and they were ok; however, as part of the pm, the fse replaced the batteries, because they were due for replacement.The iabp was then released to the customer and cleared for clinical service.
Event or Problem Description
It was reported by the customer's biomed that during use on a patient the cs300 intra-aortic balloon pump (iabp) was on batteries and when switched off, there was no ac power.Subsequently, the user switched off and on the ac power and after that the machine switched on directly.There was no harm or injury to patient and no adverse event was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h4, h10.Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period mar 2019 through feb 2021 was reviewed.There were no triggers identified for the review period.

• Brand Name: CS300
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• MDR Report Key: 11506907
• Report Number: 2249723-2021-00548
• Device Sequence Number: 16838392
• Product Code: DSP
• UDI-Device Identifier: 10607567108292
• UDI-Public: 10607567108292
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: 0998-00-3023-62
• Device Catalogue Number: 0998-00-3023-62
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/30/2021; 04/22/2021; 07/27/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/20/2021; 05/17/2021; 07/27/2021
• Patient Sequence Number: 1