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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION NEPTUNE; APPARATUS, EXHAUST, SURGICAL

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STRYKER CORPORATION NEPTUNE; APPARATUS, EXHAUST, SURGICAL Back to Search Results
Model Number 0703001000
Device Problems Thermal Decomposition of Device (1071); Melted (1385); Device Emits Odor (1425); Smoking (1585)
Patient Problem Insufficient Information (4580)
Event Date 02/12/2021
Event Type  malfunction  
Event Description
While operating we smelled a burning smell, we checked the patient and he was fine, so we called the charge nurses to come help us search the room to locate the source.While searching, we found the smell to be heavy in the area around the surgical field and noticed that the suction was powered off and had been on throughout the case.We called biomed and he came to the room and removed the suction from the operating room.Upon inspection biomed found the circuit board to be melted and burnt.Manufacturer response for waste management system, (brand not provided) (per site reporter).Troubleshooting-- i was called to operating room 7 for a strong burning smell and what they said was smoke.When i got in the room we were able to unplug the equipment.The doctor then stated he needed suction.We plugged the neptune back in and the power would not come back on.We found the smell to be coming from the neptune.I took the device back to my shop where i was able to disassemble the neptune.I found that the power board had fuse on it that was burned/melted.This is a common issue with the neptunes.I contacted stryker rep to inform him of the issue.I was also told by the rep that stryker engineers are aware of the issue and working on a fix.Contacted vendor-- spoke with vendor.They will be in tomorrow to replace the board.Repaired by vendor.
 
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Brand Name
NEPTUNE
Type of Device
APPARATUS, EXHAUST, SURGICAL
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical ct
san jose CA 95138
MDR Report Key11862822
MDR Text Key251944005
Report Number11862822
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/19/2021
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 Number0703001000
Device Catalogue Number0703001000
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2021
Event Location Hospital
Date Report to Manufacturer05/21/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/21/2021
Type of Device Usage Unknown
Patient Sequence Number1
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