MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM2400 NEW DISPLAY; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400DX

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation and the evaluation is complete.A visual inspection was performed on the returned device and noted a punctured display cable with exposed wire.A service history review and device history review were performed and found no indications of a nonconformance during the manufacture of this product.The reported condition was verified.The cause of the condition could not be determined.The device was removed from service.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the display cord of a em2400 new display was found to be damaged and frayed with exposed wires.There was no patient involvement.No additional information is available.

• Brand Name: EM2400 NEW DISPLAY
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; ni
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7704813
• MDR Text Key: 114554253
• Report Number: 1416980-2018-04456
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2018

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 Catalogue Number: 2400DX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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