MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-23 for EZ BREATHE ATOMIZER EZ-100 manufactured by Health & Life (suzhou) Co., Ltd..
[39426337]
The root cause of this complaint cannot be identified, since the device will not be returned to manufacturer. Have communicated with distributor closely and try to retrieve the defective device for further investigation. But it was confirmed that device unit will not be returned. To alleviate the malfunction scenario (no mist/ slow mist), health & life have implemented a corrective action of revising the user manual to further address the cleaning method to prevent the recurrence of no mist scenario. According to the update gathered statistics, the failure rate of no mist event is down to (b)(4). Herewith the investigation report as attachment. The user discarded the device.
Patient Sequence No: 1, Text Type: N, H10
[39426338]
(b)(4) received a device related adverse event report of lack of effect on (b)(4) 2015, that was reported as associated with the malfunction of the ez breathe atomizer. The reporter, the patient's husband, stated that the atomizer failed to produce a mist to alleviate the patient's asthma exacerbation. The reporter added that the patient used soap and water to clean the unit. During a follow-up phone call on (b)(6) 2015, the patient's husband stated that the atomizer activates with a green light; however, the atomizer does not produce a mist through the medication cup. The reporter added that the patient experienced an asthma attack on (b)(6) 2015, after the device failed to function; furthermore, the patient required medical treatment at the hospital's emergency room. The patient was using the device to alleviate wheezing associated with asthma; moreover, the patient only used the device once prior to the malfunction. At the time of the report, the reporter stated that he discarded the atomizer in the trash. The patient is a (b)(6) year old female with a past medical history that is significant for intermittent asthma. She does not have any known allergies, and she is a nonsmoker. The patient does not use other medications to alleviate her asthma symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005442893-2016-00001 |
| MDR Report Key | 5453600 |
| Date Received | 2016-02-23 |
| Date of Report | 2016-01-20 |
| Date of Event | 2015-12-17 |
| Date Mfgr Received | 2016-01-25 |
| Date Added to Maude | 2016-02-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SARAH SU |
| Manufacturer Street | NO.1428 XIANG JIANG ROAD SUZHOU NEW DISTRICT |
| Manufacturer City | SUZHOU, JIANG SU 215129 |
| Manufacturer Country | CH |
| Manufacturer Postal | 215129 |
| Manufacturer G1 | HEALTH & LIFE (SUZHOU) CO., LTD. |
| Manufacturer Street | NO. 1428, XIANG JIANG ROAD SUZHOU NEW DISTRICT |
| Manufacturer City | SUZHOU, JIANG SU 215129 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215129 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EZ BREATHE ATOMIZER |
| Generic Name | ATOMIZER |
| Product Code | CCQ |
| Date Received | 2016-02-23 |
| Model Number | EZ-100 |
| Lot Number | 121102 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTH & LIFE (SUZHOU) CO., LTD. |
| Manufacturer Address | NO. 1428, XIANG JIANG ROAD SUZHOU, JIANG SU 215129 CH 215129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-23 |