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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 7; SURGICAL LIGHT
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TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 7; SURGICAL LIGHT Back to Search Results
Model Number 4047020
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  malfunction  
Event Description
The customer alleged a cover from the spring arm fell off and landed in the sterile filed of an equipment cart.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
A hillrom service technician inspected the device and replaced the elbow covers.The device is functioning as designed.It is known that improper installation, maintenance, or collision can lead to the spring arm covers falling off.Hillrom is not aware of any serious injury, serious deterioration in the state of health of a patient, user or third person, or death as a result of this failure mode.Based on this information, no further action is required.
 
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Brand Name
ILED 7
Type of Device
SURGICAL LIGHT
Manufacturer (Section D)
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
carl zeiss strasse 7-9
saalfeld thuringen 07318
GM  07318
MDR Report Key12625359
MDR Text Key281675316
Report Number9681407-2021-00034
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number4047020
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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