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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD AC PUMP POWER CORD CSA GREY SYSTEM/DEVICE, PHARMACY COMPOUNDING

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BAXTER HEALTHCARE - ENGLEWOOD AC PUMP POWER CORD CSA GREY SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 400-100678
Device Problem Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 04/10/2017
Event Type  malfunction  
Manufacturer Narrative
The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an ac pump power cord for the main module of an unspecified acd hardware device was frayed. The reporter stated that one of the internal wires was exposed as the rubber coating had been cut. There was no patient involvement. No additional information is available.
 
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Brand NameAC PUMP POWER CORD CSA GREY
Type of DeviceSYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE - ENGLEWOOD
englewood CO
Manufacturer (Section G)
BAXTER HEALTHCARE - ENGLEWOOD
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6545956
MDR Text Key74477668
Report Number1416980-2017-03880
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400-100678
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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