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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 2) OMRON COMPAIR COMPRESSOR NEBULIZER
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OMRON (DALIAN) CO., LTD. (PLANT 2) OMRON COMPAIR COMPRESSOR NEBULIZER Back to Search Results
Model Number NE-C801
Device Problem No Flow (2991)
Patient Problem Apnea (1720)
Event Date 01/06/2021
Event Type  Injury  
Manufacturer Narrative
A postage paid label was sent to retrieve the unit for further investigation.A root cause has not been determined.It has not been confirmed if the device caused or contributed to the reported incident.However, due to the customer reporting hospitalization and receiving medical treatment, this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.
 
Event Description
On january 13, 2021, a caretaker of the end user of the nebulizer unit reported that consumer (user) went to the hospital on (b)(6) 2021 because she was not breathing.The emergency medical technician (emt) stated the unit was not nebulizing.Consumer was advised to stop using the unit.The consumer is using the adapter and has owned the unit for one year.She is using the unit as many times as she needs it throughout the day and night (six to eight times a day, two times at night).Consumer does not have a backup nebulizer.Consumer returned from the hospital on (b)(6) 2021 and has been using an inhaler.The caregiver stated that she puts 2.5 ml of medication in the cup.The caregiver thinks that the visiting nurse changed the nebulizer kit 2.5 weeks prior.The nebulizer kit is not from omron but it is hudson rci.She does not know when the filter was last changed.If you take the air hose off, you cannot feel air coming from the compressor without the tubing connected and with the tubing connected but not the medicine cup, still cannot feel air coming out.No condensation in the hose.They are not tilting the medicine cup toward them.The unit is sitting on a flat, firm surface.The blue baffle fits securely inside the cup.The unit is rinsed out every other week.The unit is regularly wiped with lysol wipes.The unit has never been cleaned with a commercial disinfectant.The parts have never been boiled.The unit normally runs about (5) minutes.Per the caregiver, the user was not breathing when emt arrived.User was hospitalized for one week and other medications were changed that had nothing to do with breathing or lungs.Other unknown tests were conducted.The caregiver declined to stay on phone any longer and stated follow-up call from quality department will upset her.Additional attempts to obtain further details from consumer were made on january 14, 15 and 18 by company representative.Unable to reach consumer or obtain further details.
 
Event Description
On (b)(6) 2021, a caretaker of the end user of the nebulizer unit reported that consumer (user) went to the hospital on (b)(6) 2021 because she was not breathing.The emergency medical technician (emt) stated the unit was not nebulizing.Consumer was advised to stop using the unit.The consumer is using the adapter and has owned the unit for one year.She is using the unit as many times as she needs it throughout the day and night (six to eight times a day, two times at night).Consumer does not have a backup nebulizer.Consumer returned from the hospital on (b)(6) 2021 and has been using an inhaler.The caregiver stated that she puts 2.5 ml of medication in the cup.The caregiver thinks that the visiting nurse changed the nebulizer kit 2.5 weeks prior.The nebulizer kit is not from omron but it is hudson rci.She does not know when the filter was last changed.If you take the air hose off, you cannot feel air coming from the compressor without the tubing connected and with the tubing connected but not the medicine cup, still cannot feel air coming out.No condensation in the hose.They are not tilting the medicine cup toward them.The unit is sitting on a flat, firm surface.The blue baffle fits securely inside the cup.The unit is rinsed out every other week.The unit is regularly wiped with lysol wipes.The unit has never been cleaned with a commercial disinfectant.The parts have never been boiled.The unit normally runs about (5) minutes.Per the caregiver, the user was not breathing when emt arrived.User was hospitalized for one week and other medications were changed that had nothing to do with breathing or lungs.Other unknown tests were conducted.The caregiver declined to stay on phone any longer and stated follow-up call from quality department will upset her.Additional attempts to obtain further details from consumer were made on (b)(6) by company representative.Unable to reach consumer or obtain further details.
 
Manufacturer Narrative
A postage paid label was sent to retrieve the unit for further investigation.A root cause has not been determined.It has not been confirmed if the device caused or contributed to the reported incident.However, due to the customer reporting hospitalization and receiving medical treatment, this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.Updated information in section h10 after investigation by manufacturer: a postage paid label was sent to retrieve the unit for further investigation.The manufacturer reviewed the qa test data/shipping inspection data and complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.The risk analysis document was reviewed and similar risk has been analyzed.The product instruction manual includes following safety information: use only omron authorized parts and accessories.Parts and accessories not approved for use with the device do not perform the expected specification or it may damage the unit.As of (b)(6) 2021, unit was not returned by consumer.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.
 
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Brand Name
OMRON COMPAIR COMPRESSOR NEBULIZER
Type of Device
COMPRESSOR NEBULIZER
Manufacturer (Section D)
OMRON (DALIAN) CO., LTD. (PLANT 2)
no. 28 dongbei er street, eco-
nomic & technical development
dalian liaoning, 11660 0
CH  116600
MDR Report Key11207142
MDR Text Key227943693
Report Number1450057-2021-00001
Device Sequence Number1
Product Code CAF
UDI-Device Identifier00073796458010
UDI-Public(01)00073796458010
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberNE-C801
Device Catalogue NumberNE-C801
Device Lot Number201805UF
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/21/2021
Distributor Facility Aware Date01/13/2021
Device Age2 YR
Event Location Home
Date Report to Manufacturer01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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