MAUDE Adverse Event Report: OMRON HEALTHCARE CO., LTD. OMRON COMPAIR COMPRESSOR NEBULIZER

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.

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)(4) 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 from importer.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 apr 12, 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.

• Brand Name: OMRON COMPAIR COMPRESSOR NEBULIZER
• Type of Device: COMPRESSOR NEBULIZER
• Manufacturer (Section D): OMRON HEALTHCARE CO., LTD.; 53 kunotsubo; terada-cho; muko-city, kyoto 61700 02; JA 6170002
• MDR Report Key: 11234108
• MDR Text Key: 228885953
• Report Number: 8030245-2021-00001
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00073796458010
• UDI-Public: (01)00073796458010
• Combination Product (y/n): N
• PMA/PMN Number: K110860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: NE-C801
• Device Catalogue Number: NE-C801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1