MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-06 for REUSABLE FLOW SENSOR ADULT/PEDIATRIC PN 53120 NA manufactured by Hamilton Medical Inc.
[5680680]
Flow sensor found to have crack while in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4645865 |
| MDR Report Key | 4645865 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-03-06 |
| Date of Event | 2015-02-24 |
| Date Facility Aware | 2015-02-24 |
| Report Date | 2015-03-06 |
| Date Added to Maude | 2015-04-01 |
| 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 | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REUSABLE FLOW SENSOR ADULT/PEDIATRIC |
| Generic Name | FLOW SENSOR |
| Product Code | BZG |
| Date Received | 2015-03-06 |
| Model Number | PN 53120 |
| Catalog Number | NA |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAMILTON MEDICAL INC |
| Manufacturer Address | RENO NV 89520 US 89520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-03-06 |