MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-19 for MERCURY * 10-55350 manufactured by Mercury Medical.
[206533]
Resuscitator bag was removed from package and inspected. It was noted that the spring in the manomater was turned sideways. The pressure manometer did not work. This was on a resuscitator used for peds and neo could have grave potential were it not discovered. No pt was involved. Manometer was installed on resuscitator by mercury at the factory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022437 |
| MDR Report Key | 343204 |
| Date Received | 2001-07-19 |
| Date of Report | 2001-07-19 |
| Date of Event | 2001-07-18 |
| Date Added to Maude | 2001-07-25 |
| 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 | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERCURY |
| Generic Name | AIRWAY PRESSURE MONITOR |
| Product Code | CAP |
| Date Received | 2001-07-19 |
| Model Number | * |
| Catalog Number | 10-55350 |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 332544 |
| Manufacturer | MERCURY MEDICAL |
| Manufacturer Address | 11300 - 49TH ST NORTH CLEARWATER FL 346224800 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-07-19 |