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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM-ECLIPSE PREAMPLIFIER; STIMULATOR, ELECTRICAL, EVOKED RESPONSE
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MEDTRONIC XOMED INC. NIM-ECLIPSE PREAMPLIFIER; STIMULATOR, ELECTRICAL, EVOKED RESPONSE Back to Search Results
Model Number DAQ916
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/02/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis found that the unit came in with channel failure.Placed in run for 8 hours.The item was cleaned, repaired, and tested to manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A health care provider (hcp) reported that a device was not working properly.There was no known patient impact.
 
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Brand Name
NIM-ECLIPSE PREAMPLIFIER
Common Device Name
STIMULATOR, ELECTRICAL, EVOKED RESPONSE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key11076192
Report Number1045254-2020-00647
Device Sequence Number11460296
Product Code GWF
UDI-Device Identifier00613994910950
UDI-Public00613994910950
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K050798
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/28/2020
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 NumberDAQ916
Device Catalogue NumberDAQ916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/02/2020
Initial Report FDA Received Date12/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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