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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS POWERLED; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number PWD700DF AIM K3
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation is on-going and the result will be included in a follow-up report.
 
Event Description
The customer reported that the light head detached during surgery.The user caught the cupola, preventing it from falling on patient.No injuries were reported.(b)(4).
 
Event Description
Factory reference number: (b)(4).
 
Manufacturer Narrative
(b)(4).Exemption # e2018005.(b)(4).The field service technician replaced the cupola and device returned to service.Maquet evaluated the device and assumes that the dual fork was broken due to an excessive mechanical force.Additionally the device was directly involved with the reported incident however was not being used for treatment or diagnosis of the patient when the event occurred.To prevent any similar event, maquet recommends in operating user manual, to check general aspect of the device as daily basis.
 
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Brand Name
POWERLED
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR 
MDR Report Key5729373
MDR Text Key48407738
Report Number9710055-2016-00041
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
PMA/PMN Number
K070442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPWD700DF AIM K3
Was Device Available for Evaluation? Yes
Device Age YR
Date Manufacturer Received05/23/2016
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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