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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD567910968
Device Problems Grounding Malfunction (1271); Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
Event Description
On (b)(6) 2020 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.
 
Event Description
On 19th of january 2021 getinge became aware of an issue with the one of our surgical lights - hled.During inspection it was revealed that there was lack of grounding and paint chipping occurred.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device and paint particles falling into sterile field are creating risk of contamination.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.The purpose of this submission is also to provide a correction of b5: describe event or problem and d1: brand name sections.This is based on the information provided by the service unit.#b5: previous describe event or problem: on 19th of january 2021 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.Corrected additional manufacturer narrative/corrected data: on 19th of january 2021 getinge became aware of an issue with the one of our surgical lights - hled.During inspection it was revealed that there was lack of grounding and paint chipping occurred.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device and paint particles falling into sterile field are creating risk of contamination.#d1: previous brand name: surgical light corrected brand name: hled.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.The purpose of this submission is solely to provide a correction of b5: describe event or problem and g4: date received by manufacturer sections provided in the initial report.This is based on the invofrmation provided by the service unit.#b5: previous describe event or problem: on 19th of january 2020 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.Corrected additional manufacturer narrative/corrected data: on 19th of january 2021 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.#g4: previous date received by manufacturer: 2020-01-19.Corrected date received by manufacturer: 2021-01-19.
 
Event Description
On 19th of january 2021 getinge became aware of an issue with the one of our surgical lights.During inspection it was revealed that there was lack of grounding.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device.
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
On 19th of january 2021 getinge became aware of an issue with the one of our surgical lights - hled.During inspection it was revealed that there was lack of grounding and paint chipping occurred.There was no injury reported however we decided to report the issue based on the potential as lack of grounding is creating risk of electrical shock for operator of the device and paint particles falling into sterile field are creating risk of contamination.It was established that when the event occurred, the surgical light did not meet its specification as lack of grounding and paint peeling occurred and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.All maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.¿ disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The lack of earth connections observed for some installed hled configurations is clearly a noncompliance with recommendations and warnings mentioned in our installation manuals.The installation was not carried out by getinge.The customer was communicated with, regarding the fact the installation is what caused the issue.We believe that all remaining devices are performing correctly in the market.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
 
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Brand Name
HLED
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
MDR Report Key11222031
MDR Text Key241237326
Report Number9710055-2021-00022
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,Followup,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberARD567910968
Device Catalogue NumberARD567910968
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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