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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG; LIGHT, SURGICAL, CEILING MOUNTED
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STRYKER-COMMUNICATIONS FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Catalog Number 0682400034
Device Problem Misassembly During Maintenance/Repair (4054)
Patient Problem No Patient Involvement (2645)
Event Date 02/08/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that while investigating a reported issue for a flickering flat panel monitor, the stryker field service technician (sfst) discovered that there was a gap present between the visum led flat panel spring arm and the horizontal arm of the suspension.The sfst proceeded to investigate this issue, and during his inspection, he discovered that the spring arm circlip, which is used to secure the spring arm to the horizontal arm of the suspension, was mis-seated.The sfst then proceeded to reinstall the spring arm and ensured it was secure by reinstalling the circlip.The sfst verified the circlip was installed properly by utilizing his go-no gauge.Afterwards functional testing of the spring arm was performed, and the spring arm was found to be operating to specification with no separation or gapping present.The equipment was then placed back into service and the issue was resolved.When asked if there were any competitor monitors or cabling installed on the visum led suspension, or if there was competitor integration installed in the operating room, the sfst replied that he did not recall seeing any competitor equipment in the operating room.The installation history for the surgical light system was reviewed and it was found that the unit was properly installed and passed final qc inspection on 22 december 2008.The service history for the suspension was also reviewed, and there were no service tickets found, indicating that the suspension has not been serviced by stryker personnel since installation.Finally, the manufacturing device history record for the device was reviewed, and the record showed that the flat panel spring arm was properly installed on the suspension and passed the circlip check and final qc checks on 22 sep 2008.Although the exact root cause of this issue is unknown, the most likely root cause would be improper service and maintenance by hospital personnel.There was no injury or adverse event reported.
 
Event Description
It was reported that while investigating a reported issue for a flickering flat panel monitor, the stryker field service technician (sfst) discovered that there was a gap present between the visum led flat panel spring arm and the horizontal arm of the suspension.There was no patient involvement, injury or adverse consequences reported.
 
Manufacturer Narrative
The mdr was filed on 0682400207, but the investigation identified the product as a flat panel spring arm, eds suspension, 15-21 kg, part #0682400034.The reported serial number for this device is (b)(4).
 
Event Description
It was reported that while investigating a reported issue for a flickering flat panel monitor, the stryker field service technician (sfst) discovered that there was a gap present between the visum led flat panel spring arm and the horizontal arm of the suspension.There was no patient involvement, injury or adverse consequences reported.
 
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Brand Name
FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
STRYKER-COMMUNICATIONS
1410 lakeside parkway #100
flower mound TX 75028
MDR Report Key8367937
MDR Text Key139217935
Report Number0002031963-2019-00002
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 health professional
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0682400034
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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