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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 ARD568330931
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided upon results of investigation.Device not returned to manufacturer.
 
Event Description
On 8th december, 2020 getinge became aware of an issue with one of surgical light powerled.As it was stated, the water was dripping from surgical light.Taking under consideration collected up to date information we decided to report this case based on potential as any drop of water could fall into sterile field and might cause contamination.
 
Manufacturer Narrative
On 8th december, 2020 getinge became aware of an issue with one of surgical lights powerled.As it was stated, the water was dripping from surgical light.Most likely issue occurred in result of water damage at customer¿s facility.Taking under consideration collected up to date information we decided to report this case based on potential as any drop of water could fall into sterile field and might cause contamination.It was established that when the event occurred, the headlight did not meet its specification as there was water inside the device and it contributed to the event.It is unknown if the device was being used for the patient treatment at the time of the event.The manufacturer subject matter experts have investigated the issue and probable root cause has been established.It was evaluated that the water most likely flows into the device from the anchorage to the cupola, resulting in retained water inside the headlight.Therefore, we conclude that the issue is related to user error.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.Based on the received details and further evaluation of available data it was revealed that the below fields require to be corrected: previous b5 describe event or problem: on 8th december, 2020 getinge became aware of an issue with one of surgical light powerled.As it was stated, the water was dripping from surgical light.Taking under consideration collected up to date information we decided to report this case based on potential as any drop of water could fall into sterile field and might cause contamination.Corrected b5 describe event or problem: on 8th december, 2020 getinge became aware of an issue with one of surgical lights powerled.As it was stated, the water was dripping from surgical light.Most likely issue occurred in result of water damage at customer¿s facility.Taking under consideration collected up to date information we decided to report this case based on potential as any drop of water could fall into sterile field and might cause contamination.Previous h4 device manufacture date: 2018-08-17.Corrected h4 device manufacture date: 2018-09-03.
 
Event Description
On 8th december, 2020 getinge became aware of an issue with one of surgical lights powerled.As it was stated, the water was dripping from surgical light.Most likely issue occurred in result of water damage at customer¿s facility.Taking under consideration collected up to date information we decided to report this case based on potential as any drop of water could fall into sterile field and might cause contamination.
 
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Brand Name
POWERLED
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
MDR Report Key11010798
MDR Text Key222053717
Report Number9710055-2020-00510
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,foreig
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberARD568330931
Device Catalogue NumberARD568330931
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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