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 2017-09-28 for MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY 001-372500 manufactured by Vyaire Medical, Inc.
[87849393]
(b)(4). A vyaire field service representative (fsr) went onsite to evaluate the device. The fsr determined that the box calibration could not be performed. Constant 'close door' error message appears and a burning smell was noticed. He localized the issue to the interface card where an ic chip on the card began to melt. A replacement card was installed and the device meets all factory specifications. If additional information becomes available, it will be submitted in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[87849394]
The customer reported the impulse oscillometer (ios) that is connected to the system is getting general initialization failed, ios not found. It is unknown if there was any patient impact or harm associated with the event.
Patient Sequence No: 1, Text Type: D, B5
[113691200]
At the time of the initial submission the failure investigation report was not included. Results of investigation: the vyaire failure analysis laboratory received the system box however no investigation could be performed due to the part being returned improperly packaged, without a cover or an electro-static discharge bag, compromising the functionality of the pcbas.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2017-06718 |
| MDR Report Key | 6902880 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-28 |
| Date of Report | 2018-01-08 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2018-01-08 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2017-09-28 |
| 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 | KRISTIN GRAF |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY |
| Generic Name | PLETHYSMOGRAPH, VOLUME |
| Product Code | JEH |
| Date Received | 2017-09-28 |
| Returned To Mfg | 2017-09-06 |
| Catalog Number | 001-372500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | LEIBNIZSTRASSE 7 HOECHBERG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-28 |