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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS MULTIMEDIA LIGHT, SURGICAL

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DRÄGERWERK AG & CO. KGAA POLARIS MULTIMEDIA LIGHT, SURGICAL Back to Search Results
Catalog Number G16915
Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation was started; the results will be provided in a follow-up report.
 
Event Description
It was reported that the affected boom with the spring arm and monitor fell down during an ongoing operation and landed next to the patient on the operating table. As a result, the table top was bent. The ongoing operation could still be completed, after that the operating room was closed for use. No persons were harmed in the event, neither the patient nor the users.
 
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Brand NamePOLARIS MULTIMEDIA
Type of DeviceLIGHT, SURGICAL
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key13786497
MDR Text Key294656324
Report Number9611500-2022-00072
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG16915
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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