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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED MOBILE CART CAMERA

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NATUS MEDICAL INCORPORATED MOBILE CART CAMERA Back to Search Results
Model Number 10295
Device Problems Device Damaged Prior to Use (2284); Defective Device (2588)
Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Event Type  Malfunction  
Manufacturer Narrative

Mobile cart camera has fallen on the eeg technician head.

 
Event Description

Mobile cart camera fell on the eeg technician head.

 
Search Alerts/Recalls

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Brand NameMOBILE CART CAMERA
Type of DeviceMOBILE CART CAMERA
Manufacturer (Section D)
NATUS MEDICAL INCORPORATED
dba excel-tech ltd. (xltek)
2568 bristol circle
oakville, ontarios L6H 5 S1
CA L6H 5S1
Manufacturer (Section G)
NATUS MEDICAL INCORPORATED
dba excel-tech ltd. (xltek)
2568 bristol circle
oakville, ontario L6H 5 S1
CA L6H 5S1
Manufacturer Contact
michelle greaney
ida business park
gort
galway, H91PD-92
EI   H91PD92
MDR Report Key9805143
MDR Text Key200609000
Report Number9612330-2020-00003
Device Sequence Number1
Product Code FTT
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10295
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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