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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; SLEEP EQUIPMENT MAINTENANCE SYSTEM
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SOCLEAN, INC. SOCLEAN 2; SLEEP EQUIPMENT MAINTENANCE SYSTEM Back to Search Results
Model Number SC1200
Device Problem Insufficient Information (3190)
Patient Problems Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/22/2021
Event Type  Injury  
Event Description
Customer reports a pre-existing cardiac conditions, heart blockage/aneurysm, along with dizziness and exacerbation of copd with md intervention requiring surgery to remove aneurysm/blockage and also received medication to treat copd.
 
Manufacturer Narrative
File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Soclean disputes the statements made by philips related to ozone and the philips recall.We will maintain a record of your injury.Please consult with your physician or a medical professional if your injury continues.A clinical investigation was performed.The customer states cardiac and respiratory symptoms.The md was seen and advised the customer to discontinue use of both the pap and sc.The customer states that some of his symptoms have subsided after use of an inhaler however his cardiac symptoms did not subside until after surgery.Due to both devices being discontinued at the same time with multi preventable treatment being done it is reasonable to assume that the soclean was not completely at fault for all of the symptoms described.In addition, this customer was using a philips device, in which has been recalled and additional information has been provided on the investigation tab to justify root cause.We are deeming this reportable for diligence.Continue to track and trend.
 
Manufacturer Narrative
File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Soclean disputes the statements made by philips related to ozone and the philips recall.We will maintain a record of your injury.Please consult with your physician or a medical professional if your injury continues.A clinical investigation was performed.The customer states cardiac and respiratory symptoms.The md was seen and advised the customer to discontinue use of both the pap and sc.The customer states that some of his symptoms have subsided after use of an inhaler however his cardiac symptoms did not subside until after surgery.Due to both devices being discontinued at the same time with multi preventable treatment being done it is reasonable to assume that the soclean was not completely at fault for all of the symptoms described.In addition, this customer was using a philips device, in which has been recalled and additional information has been provided on the investigation tab to justify root cause.We are deeming this reportable for diligence.Continue to track and trend.
 
Event Description
Customer reports a pre-existing cardiac conditions, heart blockage/aneurysm, along with dizziness and exacerbation of copd with md intervention requiring surgery to remove aneurysm/blockage and also received medication to treat copd.
 
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Brand Name
SOCLEAN 2
Type of Device
SLEEP EQUIPMENT MAINTENANCE SYSTEM
Manufacturer (Section D)
SOCLEAN, INC.
12 vose farm road
peterborough NH 03458
Manufacturer (Section G)
SOCLEAN, INC.
12 vose farm road
peterborough NH 03458
Manufacturer Contact
anne nadeau
12 vose farm road
peterborough, NH 03458
6033712533
MDR Report Key12846442
MDR Text Key285225722
Report Number3009534409-2021-00461
Device Sequence Number1
Product Code LRJ
UDI-Device Identifier00187293000860
UDI-Public187293000860
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSC1200
Device Catalogue NumberSC1200
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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