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

Catalog Number 0998-00-3023-53

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit is not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. This complaint is being closed due to insufficient information from the customer after four (4) attempts were made to obtain the relevant information. If any further information is provided in the future, a follow up mdr will be submitted.

Event Description

The customer biomed reported that on a new color video receiver printed circuit board (pcb) he had ordered, there was a bad connection. He stated that his old pcb connection is solid and is returning the new ordered part for a replacement. Getinge service has not been requested as the customer will be making their own repairs. This event occurred during service/testing by the customer. No patient was involved and no adverse event was 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: 6751601
• MDR Text Key: 81479589
• Report Number: 2249723-2017-00175
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse