MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-01 for HME TYPE I ADULT 003003 manufactured by Vyaire Medical.
[143941635]
Vyaire has reached out to customer three times to request the complaint sample for further investigation. A ups label was also provided to the customer. Unfortunately, vyaire has not received the complaint sample for evaluation. If a sample or any additional information becomes available a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[143941636]
A customer contacted vyaire to report that the hme 0003003 was breaking apart while on patients. The patient was receiving ventilation therapy when the issue occurred. The issue was discovered when staff had noticed loss in vent pressure and the ventilation had alarmed. They had to replace the unit with a new 003003. The circuit was set-up with the hme between the circuit and the patient. No patient harm was indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005515211-2019-00004 |
| MDR Report Key | 8570920 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-01 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-05-16 |
| Date Added to Maude | 2019-05-01 |
| 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 | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | AMSINO MEDICAL (SHANGHAI) CO. LTD |
| Manufacturer Street | BLDNG 1-3, LANE 355 HUAZHE RD SONGJIANG EXP PRCSSNG ZONE |
| Manufacturer City | SHANGHAI, 201613 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 201613 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HME TYPE I ADULT |
| Generic Name | CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) |
| Product Code | BYD |
| Date Received | 2019-05-01 |
| Catalog Number | 003003 |
| Lot Number | SJ0718022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-01 |