MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 2) COMPAIR NEBULIZER SYSTEM

Model Number NE-C801

Device Problem Infusion or Flow Problem (2964)

Patient Problem Dyspnea (1816)

Event Date 12/17/2022

Event Type  Injury  

Event Description

The consumer called on (b)(6) 2023 and stated that on (b)(6) 2022, the consumer's ex-husband drove her to the hospital for breathing treatment due to her difficulty breathing.She received a prescription for medication (albuterol) and a nebulizer.On (b)(6) 2022, she received the unit and used it 2-3 times at 7am or 8am, 2pm, 7pm, then at 11:30pm.During the last time she tried to do a treatment, her unit would not work.The consumer's ex-husband tried to help get the nebulizer to work, and when he couldn't, he called an ambulance for her since she could not breathe.She claimed that she temporarily died on the way to the hospital and was revived.She was hospitalized 4 days.Follow-up calls were made to the consumer on (b)(6) 2023 with no response.The consumer responded to a follow-up call on (b)(6) 2023.She stated that she was 52 years old.She took treatments because she had allergy induced asthma and had an inhaler on hand.The medication she took was albuterol with a dilution ratio of 0.083%.She stated did not clean the unit since she had it for a day and a half.She would rinse the unit out and let it air dry between uses.She stated she did one treatment at 8 am and then another before going to bed.She then woke up at 11:38 pm because she could not breathe.She stated she threw something at her ex-husband to get his attention and get the unit set up.She stated the unit did not work; it would not nebulize.She stated that she had passed away in the ambulance and that she was not "there" when the emts brought her back from passing away.She did not know what they did and had not received the bill yet.She stated the event occurred on (b)(6) 2022, but she was in the hospital for a while and did not have a chance to call.She stated was hospitalized for 4 days with pneumonia the week after the event and that she had stage 4 cancer.

Manufacturer Narrative

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 having been resuscitated and hospitalized, this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.A postage label has been sent for retrieval of the home unit for inspection.

Event Description

The consumer called on 1/18/2023 and stated that on (b)(6) 2022, the consumer's ex-husband drove her to the hospital for breathing treatment due to her difficulty breathing.She received a prescription for medication (albuterol) and a nebulizer.On (b)(6) she received the unit and used it 2-3 times at 7am or 8am, 2pm, 7pm, then at 11:30pm.During the last time she tried to do a treatment, her unit would not work.The consumer's ex-husband tried to help get the nebulizer to work, and when he couldn't, he called an ambulance for her since she could not breathe.She claimeed that she temporarily died on the way to the hospital and was revived.She was hospitalized 4 days.Follow-up calls were made to the consumer on 1/18/2023, 1/20/2023, and 1/23/2023 with no response.The consumer responded to a follow-up call on 2/14/2023.She stated that she was 52 years old.She took treatments because she had allergy induced asthma and had an inhaler on hand.The medication she took was albuterol with a dilution ratio of 0.083%.She stated did not clean the unit since she had it for a day and a half.She would rinse the unit out and let it air dry between uses.She stated she did one treatment at 8 am and then another before going to bed.She then woke up at 11:38 pm because she could not breathe.She stated she threw something at her ex-husband to get his attention and get the unit set up.She stated the unit did not work; it would not nebulize.She stated that she had passed away in the ambulance and that she was not "there" when the emts brought her back from passing away.She did not know what they did and had not received the bill yet.She stated the event occurred on 12/19/2022, but she was in the hospital for a while and did not have a chance to call.She stated was hospitalized for 4 days with pneumonia the week after the event and that she had stage 4 cancer.

Manufacturer Narrative

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 having been resuscitated and hospitalized, this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.A postage label has been sent for retrieval of the home unit for inspection.Updated information in section d9 and f7.Additional information added to section h10.After initial report was submitted, the consumer returned the unit back to importer for evaluation.During evaluation of the unit, it was noted that air hose sent by customer was not compatible with the omron unit.The medicine cup sent in by consumer was broken.However, the unit did pass the inspection (evaluation) with sample air hose and medication cup.Then, the returned unit was sent to device manufacturer for further testing.Additional follow-up was requested from the consumer.She provided the following information: the consumer stated the she believed she used the air hose that came with the unit.She only used what originally came in the box.She believes the air hose sent to omron may have been from child's whale nebulizer.She stated that her husband may have grabbed the wrong air hose when he was trying to get the unit to work.She was not aware of damage to the medication cup when sent it.Here is the summary of the manufacturer device investigation: during investigation the main unit was found to be a normal product.The cause of no nebulization was determined to be a damaged nozzle of the medication cup.The consumer had stated that the device could be used two or three times after purchase.Since there were many scratches inside the medication cup, it is presumed that the consumer tried to widen the hole of the nozzle and it broke.The air tube and mouthpiece the consumer sent were not omron accessories.It is presumed they were returned by mistake as parts from a children's nebulizer based on further follow-up from the consumer.The instruction manual includes the following cautions regarding the handling of the medication cup nozzle: "inspect the compressor (main unit) and the nebulizer parts each time before using nebulizer kit.Make sure no parts are damaged, the nozzle and air tube are not blocked and the compressor operates normally." and "do not alter the baffle, the nozzle in the medication cup or any part of the nebulizer kit." the manufacturer reviewed the qa test data, post market data/complaint history for similar issues.No issue/problem was noted during data reviewed by the manufacturer.No issue or no increasing trend was noted for complaint data review.The risk analysis document was reviewed and it was determined that no update to risk management documents is required.Since there was no issue found with returned device; further investigation and correction is not necessary.

• Brand Name: COMPAIR NEBULIZER SYSTEM
• Type of Device: NEBULIZER
• Manufacturer (Section D): OMRON (DALIAN) CO., LTD. (PLANT 2); no. 28 dongbei er street, eco-; nomic & technical development; dalian liaoning, cn 11660 0; CH 116600
• MDR Report Key: 16375967
• MDR Text Key: 309551094
• Report Number: 1450057-2023-00002
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00073796458010
• UDI-Public: (01)00073796458010
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NE-C801
• Device Catalogue Number: NE-C801
• Device Lot Number: 202207UF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2023
• Distributor Facility Aware Date: 01/18/2023
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 02/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Female