MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for NEBULIZER COMPRESSOR MACHINE C N -02 M N ZRCNO1 manufactured by Unk.
[133531372]
Got first nebulizer machine on (b)(6) 2018 called (b)(6) pharmacy on (b)(6) 2018, was told by them to return it. The nebulizer was returned because it had strong chemical smell coming from the machine (without the hose hooked to it). Could taste the chemical in my mouth. I used the 2nd machine only 2 days because it too had a strong chemical taste and smell coming from it also. Was told by (b)(6) pharmacy before i return the 2nd machine, i had to call cardinal health and get the ok from them. Cardinal health said it was ok to return the 2nd machine to (b)(6) pharmacy so i did on (b)(6) 2018. I got a replacement nebulizer machine for a different mfr(philips) and there was no chemical smell or taste from it. Cardinal health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083186 |
| MDR Report Key | 8254019 |
| Date Received | 2019-01-15 |
| Date of Report | 2019-01-12 |
| Date of Event | 2018-09-10 |
| Date Added to Maude | 2019-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| 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 | 0 |
| Brand Name | NEBULIZER COMPRESSOR MACHINE |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2019-01-15 |
| Model Number | C N -02 M N |
| Catalog Number | ZRCNO1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | NEBULIZER COMPRESSOR MACHINE |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2019-01-15 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-01-15 |