MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-03 for MICROSTREAM 010579 manufactured by Oridion Medical.
[188101939]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188101940]
According to the reporter, the unit had reading issue and the filter line had an occlusion. The patient was reintubated with reports of moderated pain and discomfort.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8044004-2020-00002 |
| MDR Report Key | 9781625 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-07-18 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | ORIDION MEDICAL |
| Manufacturer Street | 7 HAMARPEH ST. |
| Manufacturer City | JERUSALEM 91235 |
| Manufacturer Country | IL |
| Manufacturer Postal Code | 91235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSTREAM |
| Generic Name | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| Product Code | CCK |
| Date Received | 2020-03-03 |
| Model Number | 010579 |
| Catalog Number | 010579 |
| Lot Number | 19F0514JZ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORIDION MEDICAL |
| Manufacturer Address | 7 HAMARPEH ST. JERUSALEM 91235 IL 91235 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |