MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-02 for HYDRO-GUARD MINI BREATHING FILTER 1745030 manufactured by Intersurgical Uab.
[115810616]
The patient was on the vent and was also on an aerosolized medication. The doctor and therapist were in the room when the vent stopped working due to occlusion. The filter was subsequently changed and corrected the situation. The application of medication could have directly contributed to occluding the filter and blockage. Per the ifu "do not use this product between the patient and a source of nebulized drugs" and "when nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure". Initial usage would indicate the filter operated as intended prior to administration of medicine.
Patient Sequence No: 1, Text Type: N, H10
[115810617]
Product was causing problem with ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319447-2018-00006 |
| MDR Report Key | 7742777 |
| Date Received | 2018-08-02 |
| Date of Report | 2018-08-02 |
| Date Mfgr Received | 2018-07-05 |
| Date Added to Maude | 2018-08-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. IVAN SENIUT |
| Manufacturer Street | ARNIONIU 60/28-1 |
| Manufacturer City | PABRADE, VILNIAUS APSKRITIS, LT-4710 |
| Manufacturer Country | LH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRO-GUARD MINI BREATHING FILTER |
| Generic Name | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| Product Code | CAH |
| Date Received | 2018-08-02 |
| Model Number | 1745030 |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSURGICAL UAB |
| Manufacturer Address | ARNIONIU 60/28-1 PABRADE, VILNIAUS APSKRITIS LT-4710, LH LH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-02 |