MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for LOW RANGE FLOWMETER KIT NO. 537-1 NA manufactured by Respironics Novametrix, Llc.
[30706924]
Patient Sequence No: 1, Text Type: N, H10
[30706925]
Patient is getting oxygen equipment from a home care medical and respiratory equipment provider. The parents are reporting that the humidification bubble malfunctioned which caused water to get into the nasal cannula tubing and then from there into the nasal/oral pharynx. This caused the patient to have to go to the hospital where she presented with hypoxia. The attending doctor would like to have that equipment picked up and brought into the hospital for inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5210377 |
| MDR Report Key | 5210377 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-11-06 |
| Date of Event | 2014-08-05 |
| Report Date | 2015-06-25 |
| Date Reported to FDA | 2015-06-25 |
| Date Reported to Mfgr | 2015-06-25 |
| Date Added to Maude | 2015-11-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | LOW RANGE FLOWMETER |
| Generic Name | FLOWMETER, CALIBRATION, GAS |
| Product Code | BXY |
| Date Received | 2015-11-09 |
| Model Number | KIT NO. 537-1 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS NOVAMETRIX, LLC |
| Manufacturer Address | 5 TECHNOLOGY DRIVE WALLINGFORD CT 06492 US 06492 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-09 |