MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for OMRON COMPAIR COMPRESSOR NEBULIZER NE-C801 manufactured by Omron (dalian) Co., Ltd. (plant 2).
[174256478]
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 and ac adapter caused spark/fire, this medwatch is being filed. The u. S importer is requesting the manufacturer of the device to further investigate this incident.
Patient Sequence No: 1, Text Type: N, H10
[174256479]
The pharmacy representative called and informed that consumer returned the unit to pharmacy because ac adapter and unit caught fire. Omron consumer service representative advised pharmacy representative to not to replace any units for this reason and to have consumer contact omron directly. The caller did not know how long the unit was used for nor had proof of purchase. The caller also did not know how long the consumer had the unit for nor how long she had the ac adapter plugged in. The ac adapter was badly burned so cannot read if it is manufactured by omron or not. The caller did not have any additional information. During follow-up call on jan 2, 2020, the pharmacist stated unit was returned to pharmacy and what he knows is that the adapter threw out sparks but did not cause fire. The pharmacist was asked if he had consumer contact information so omron can speak to consumer directly. The pharmacist stated the unit was not returned directly to him and the person who got the unit back is not available at this time. Another follow-up call was made on jan 3, 2020 to obtain additional information. Unable to get in touch with contact at pharmacy. Omron representative spoke to pharmacist (who had taken the unit back from consumer) on jan 6, 2020. This pharmacist also did not have consumer contact information. The pharmacist was told that the adapter started on fire but that it. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1450057-2019-00003 |
| MDR Report Key | 9566463 |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-12-01 |
| Date Facility Aware | 2019-12-31 |
| Report Date | 2020-01-08 |
| Date Reported to FDA | 2020-01-08 |
| Date Reported to Mfgr | 2020-01-08 |
| Date Added to Maude | 2020-01-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMRON COMPAIR COMPRESSOR NEBULIZER |
| Generic Name | COMPRESSOR NEBULIZER |
| Product Code | CAF |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2020-03-12 |
| Model Number | NE-C801 |
| Catalog Number | NE-C801 |
| Lot Number | 20161103911UF |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 37 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRON (DALIAN) CO., LTD. (PLANT 2) |
| Manufacturer Address | NO. 28 DONGBEI ER STREET, ECO- NOMIC & TECHNICAL DEVELOPMENT DALIAN LIAONING, 116600 CH 116600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |