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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM2400, DISPLAY MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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BAXTER HEALTHCARE CORPORATION EM2400, DISPLAY MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 2400D
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the display cord of an em 2400, display module was observed frayed.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed, and the power cable insulation was observed torn and exposing the braided ground wire shielding.No internal conductive wires can be seen.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was due to normal everyday use.To correct the condition, the power cable assembly was replaced.The device was serviced to meet functional specification.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available a supplementary report will be submitted.
 
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Brand Name
EM2400, DISPLAY MODULE
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10636605
MDR Text Key210163310
Report Number1416980-2020-06231
Device Sequence Number1
Product Code NEP
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2400D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Date Manufacturer Received01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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