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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS BLUE; LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET SAS BLUE; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number BLUE30
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by manufacturing site.(b)(4).(b)(6).
 
Event Description
On (b)(6) 2018 (b)(4) became aware of an incident with one of surgical lights blue 30.As it was stated, the glass cracked on the device during surgical procedure.There is no injury reported however we decided to report the issue in abundance of caution as any part falling during surgery or into sterile field might be a source of contamination.Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
(b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturers reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is being investigated by manufacturing site.
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
Getinge became aware of an incident with one of the blue 30 surgical lights.As it was stated, the underside cover cracked on the device during surgical procedure.There is no injury reported however we decided to report the issue in abundance of caution as any part falling during surgery or into sterile field might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification.At the time when the event occurred the device was being used for the patient treatment.During the investigation, it was found that the reported scenario is a single and isolated case for this model type.The event was caused by misuse of the device by the customer.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074.Exemption # e2018005.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer's reference number (b)(4).
 
Event Description
Manufacturer's reference number 2018- 61685.
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
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Brand Name
BLUE
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR 
MDR Report Key8186816
MDR Text Key131380651
Report Number9710055-2018-00200
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,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBLUE30
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Initial Date Manufacturer Received 11/28/2018
Initial Date FDA Received12/20/2018
Supplement Dates Manufacturer Received11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
11/28/2018
12/11/2019
Supplement Dates FDA Received01/17/2019
02/07/2019
03/05/2019
03/29/2019
04/18/2019
05/14/2019
06/05/2019
06/28/2019
07/23/2019
08/19/2019
09/13/2019
10/08/2019
10/31/2019
11/22/2019
12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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