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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM

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ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM Back to Search Results
Model Number 3600-100
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2021
Event Type  malfunction  
Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
 
Event Description
Icu rn who is also the educator, called to question whether the suction tubing could be direct from the wall regulator to the drain, or had to go through a suction canister (collection canister).She expressed dissatisfaction with the diagram for setup that she found online, as well as the fact that no instructions come with the individual drain.It was explained to her that it is irrelevant whether a suction canister is used or not, as long as all the openings on the canister are capped.She was pleased with the help and looks forward to contact from her local rep regarding available posters, etc.She describes their facility as infrequent users, but that this is the drain they always use.
 
Manufacturer Narrative
A complaint was submitted as a result of a technical support call received regarding oasis 3600-100 and a question on suction application.The complaint details state: "icu rn who is also the educator, called to question whether the suction tubing could be direct from the wall regulator to the drain, or had to go through a suction canister (collection canister).She expressed dissatisfaction with the diagram for setup that she found online, as well as the fact that no instructions come with the individual drain.I explained that it is irrelevant whether a suction canister is used or not, as long as all the openings on the canister are capped.She was pleased with the help and looks forward to contact from her local rep regarding available posters, etc.She describes their facility as infrequent users, but that this is the drain they always use." the territory manager subsequently provided the hospital with oasis wall posters, wallet cards, and personal guide booklets.In addition, in-service training was conducted with the staff.There is no specific device involved in this complaint and no report of device malfunction; therefore, a device evaluation is not required and the complaint is not considered confirmed.As requests for technical support that do not involve possible malfunction/failure are not considered complaints therefore, the focus of this investigation is on the reported dissatisfaction with the labeling configuration (i.E.The fact that no instructions come with the individual drain), and a review of the content of the labeling provided with the drain in regards to suction setup.The ifu was found to contain adequate instruction regarding suction setup.A number of warnings and precautions to ensure proper setup and function of the drain and description of the various features of the drain.There is an image of the drain and features provided, which clearly denotes the suction control regulator, suction monitor, and suction port.The ifu does not require the use of a canister or collection chamber in order to use suction.The iconic ifu provides a graphical depiction of the drain setup, including connection of the suction line, adjustment of the suction regulator, and bellows monitor.A risk review was performed, which concluded that the device is operating within its approved risk profile, and that the risk analysis adequately covers this complaint.Based on the investigation, no labeling deficiencies have been identified with regard to the use of suction.The ifu does not require the use of a suction canister.With regard to the user dissatisfaction with the ifu configuration (i.E.The fact that instructions are not provided with the individual drain), there have been no other related complaints since october 2020.Therefore, root cause is user - user preference issue.H3 other text: no device available.
 
Event Description
N/a.
 
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Brand Name
DRAINS OASIS SINGLE
Type of Device
BOTTLE, COLLECTION, VACUUM
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer Contact
lori gosselin
40 continental blvd
merrimack, NH 
MDR Report Key13110551
MDR Text Key284905741
Report Number3011175548-2021-01352
Device Sequence Number1
Product Code KDQ
UDI-Device Identifier00650862110012
UDI-Public00650862110012
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 03/01/2023
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 Number3600-100
Device Catalogue Number3600-100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2021
Initial Date FDA Received12/29/2021
Supplement Dates Manufacturer Received01/05/2023
02/23/2023
Supplement Dates FDA Received01/06/2023
03/01/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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