MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-12-12 for CIRCUIT, ADULT SINGLE-LIMB, HEATED AH202 manufactured by Vyaire Medical, Inc.
[94506688]
Initial emdr submission: sample is available, ups shipping labels provided to customer to have the sample returned. Currently awaiting for the sample. Once the investigation is complete a follow up submission will be filed.
Patient Sequence No: 1, Text Type: N, H10
[94506689]
Customer reports that the temperature probe becomes dislodged from the circuit at the humidification chamber when using with high flow nasal cannula. Today our day shift supervisor reported to me that we have had several rapid responses called for hypoxia due to the temperature probe being dislodged down and the heater pot. Our previous circuit had a clip to keep this in place, can the manufacturer correct this with. On 12/4/2017-additional information: product sample is available. Clinician was made aware of the issue because saturations dropped. No medical intervention required other than correcting the issue. Details of the "rapid responses" described by customer as: "patients oxygen saturations dropped, nursing could not find the issue and rapid response called". On 08dec2017-additional information from customer: yes this product has not changed since we began using them, clinicians we aware when the patients pulse oximeter alarm went off, a rrt was called but devices were corrected, previous circuit had a clip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00393 |
| MDR Report Key | 7108072 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-12 |
| Date of Report | 2018-03-27 |
| Date of Event | 2017-11-28 |
| Date Mfgr Received | 2018-02-28 |
| Date Added to Maude | 2017-12-12 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 N RIVERWOOD BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO. 85., PARQUE INDUSTRIAL MEX |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRCUIT, ADULT SINGLE-LIMB, HEATED |
| Generic Name | OXYGEN ADMINISTRATION KIT |
| Product Code | OGL |
| Date Received | 2017-12-12 |
| Catalog Number | AH202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 26125 N RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-12-12 |