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 2018-06-26 for VYNTUS/SENTRY/SUITE PRODUCT LINE MASTERSCREEN CPX 1 MS-CPX 1 manufactured by Vyaire Medical, Inc.
[112417570]
(b)(4). At this time, vyaire has not received the suspect device/component for evaluation. If additional information becomes available, it will be submitted in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[112417571]
The customer reported that there was a possible leak from the system during dlco testing, and the exercise physiologist and patient complained of feeling light headed. Biomedical turned off the gas and all seemed better. The patient had no ill effect, but the exercise physiologist reported to the emergency room, which resulted in 4 days of missed work. No diagnosis for the illness was provided. Employee returned to work with no continuing issues from this event.
Patient Sequence No: 1, Text Type: D, B5
[114583188]
Device was evaluated at customer facility. Field service engineer installed replacement demand valve and allowed customer to test system with no problems.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2018-08015 |
| MDR Report Key | 7638067 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2018-06-29 |
| Date Added to Maude | 2018-06-26 |
| 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 | MS. AVERY FOSTER |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | LEIBNIZSTRASSE 7 |
| Manufacturer City | HOECHBERG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VYNTUS/SENTRY/SUITE PRODUCT LINE |
| Generic Name | PULMONARY-FUNCTION DATA CALCULATOR |
| Product Code | BZC |
| Date Received | 2018-06-26 |
| Model Number | MASTERSCREEN CPX 1 |
| Catalog Number | MS-CPX 1 |
| 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, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-26 |