MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-10 for DELTECH 8M50 NA manufactured by Deltech Engineering Century Park.
[69177]
The dryer on the medical air supply system failed to remove water and the line monitor failed to alarm. The water in the system caused the flow sensor on the ventilator to alarm. However the ventilator continued to operate. The ventilator was exchanged without pt compromise.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 111821 |
| MDR Report Key | 111821 |
| Date Received | 1997-07-10 |
| Date of Report | 1997-04-11 |
| Date of Event | 1996-09-08 |
| Date Facility Aware | 1996-09-12 |
| Report Date | 1997-04-11 |
| Date Added to Maude | 1997-08-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTECH |
| Generic Name | MEDICAL AIR DRYER |
| Product Code | FRF |
| Date Received | 1997-07-10 |
| Model Number | 8M50 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 109791 |
| Manufacturer | DELTECH ENGINEERING CENTURY PARK |
| Manufacturer Address | PO BOX 667 NEW CASTLE DE 19720 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-07-10 |