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

Model Number NE-C801

Device Problem No Flow (2991)

Patient Problem Apnea (1720)

Event Date 02/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A replacement unit was sent to customer.Consumer was advised to stop using the unit.A postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made.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 stating that unit was not nebulizing and she was taken to emergency room and received the medications and iv, this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.

Event Description

The consumer reported that her unit is not nebulizing but she did not know it.She could not breathe on (b)(6) 2018 and her children took her to emergency room.Per the consumer, at the emergency room, they administered a double dose of medication and started an iv.They also gave her a prescription for a steroid for the inflammation that was caused from her lack of getting medication with her nebulizer.The consumer was using 3ml of medication for 3 times per day for 10 to 15 minutes for each treatment.The consumer has not replaced the neb kit but cleaned it after every use.Per the consumer, the filter has not been replaced.The consumer was advised to stop using the unit and a postage paid label was sent to her for retrieval of the unit for further investigation.During a follow-up call with the quality department, the consumer stated that she was not getting her medication for a long period of time so she had to be rushed to hospital.She said that she could not breathe.She has purchased another unit but she would like a replacement unit.The consumer was advised to return the unit for further investigation.The consumer was informed that a replacement unit will be sent to her as soon as possible.The consumer stated that she has a preexisting medical condition of sleep apnea, which resulted in causing lung damage.She has been using a nebulizer 3 times per day for about 2 years.The consumer stated that she had major surgery due to vaginal cancer and is still recovering from it.The consumer stated that she is not feeling well and refused to provide any additional information.The consumer was advised to send the unit for further investigation.

Manufacturer Narrative

Exemption number: e2013031.Omron healthcare.Inc.(importer) is submitting the report on behalf of omron (dalian) co., ltd.(plant 2) (manufacturer).Registration number: (b)(4).A postage paid label was sent to facilitate retrieval of the unit for further investigation.Unit not returned for further investigation.The manufacturer reviewed the device history records, qa test data and risk analysis, complaint history for the model number and similar models and complaint records for similar issues.The shipping information was reviewed.No issue/problem was noted during data reviewed by the manufacturer.All risk mitigations, warnings and cautions are still correct, and in place.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.

• Brand Name: 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 Key: 7323808
• MDR Text Key: 101888071
• Report Number: 3003263296-2018-00003
• Device Sequence Number: 1
• Product Code: CAF
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• 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: 20160802500UF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/20/2018
• Device Age: 18 MO
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization