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 2018-01-03 for CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT AH280 manufactured by Vyaire Medical, Inc.
[96332952]
(b)(4). Vyaire has reached out to customer to provide the complaint device for further investigation. A ups label has been provided to the customer. Unfortunately, vyaire has not received the complaint device for evaluation or the requested additional information at this time. If a sample or any additional information becomes available a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96332953]
Customer reported "transporting and the vent had? Leak? Disconnect? , by the time i got there they had swapped over to another vent. The temp probe had popped out at the heater chamber. Looking at it more i am thinking the temp probe wire (gray) is twisting the temp probe, and the blue? V? Is casing the temp probe to pop out. The three white temp probe wire keepers are all close to the patient y. So during transport the gray temp wire can swing and loosen up or twist the temp probe". Customer reported that there was no patient injury or death. The patient had a low spo2 related to the disconnect. "the team started bagging patient and sat went back up". "they did not see the temp probe was out at that time, during transport it is a time of high stress. Patient ok, vent was changed out with new circuit". The lot number is not available.
Patient Sequence No: 1, Text Type: D, B5
[109276767]
Device evaluation: the actual device was not available for evaluation; however, a photo of the device was provided. In the photo the temperature probe was hanging loose. This could cause the probe to get stuck and pulled while it is being moved during use. This could cause the disconnection reported by the customer. It was also observed in the photo that the three hose clips are not in proper placement along the purple tube. The clips should be placed at approximately every one quarter of the tube as stated in the drawing and manufacturing procedure. Based on the investigation it is possible that the reported disconnection was related to incorrect positioning of the hose clips. The manufacturing procedure fives the responsibility to the operator to place the hose clips in the proper position according to the drawing. Vyaire has taken the following actions. Manufacturing personnel have been notified of the reported issue. Reference marks were placed on the assembly station to assist the operator with correct placement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2018-00400 |
| MDR Report Key | 7161623 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-03 |
| Date of Report | 2018-04-18 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2018-03-15 |
| Date Added to Maude | 2018-01-03 |
| 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 NORTH RIVERWOODS 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 |
| 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 DUAL-LIMB, DUAL-HEAT |
| Generic Name | OXYGEN ADMINISTRATION KIT |
| Product Code | OGL |
| Date Received | 2018-01-03 |
| Catalog Number | AH280 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-03 |