MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for HME TYPE I ADULT 50/CS 003003-A manufactured by Vyaire Medical.
[117566687]
At this time, vyaire has not received the suspect device/component for evaluation. If additional information is received a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[117566688]
The customer reported that a small plastic piece was observed to be stuck in the filter. The event happened during patient use. All of a sudden the patient had stopped breathing and the ventilator kept alarming, so the staff immediately switched to the ambu-bag and stabilized the patient. No further patient impact was indicated. Upon retracing their steps, the staff discovered a plastic piece in the filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005515211-2018-00001 |
| MDR Report Key | 7795394 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-08-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | AMSINO MEDICAL (SHANGHAI) CO., LTD. |
| Manufacturer Street | NO. 355 HUAZHE ROAD |
| Manufacturer City | SHANGHAI, |
| Manufacturer Country | TW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HME TYPE I ADULT 50/CS |
| Generic Name | CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) |
| Product Code | BYD |
| Date Received | 2018-08-17 |
| Catalog Number | 003003-A |
| Lot Number | SJ111705 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-17 |