MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-03-15 for SENSORMEDICS VMAX ENCORE 29 777408-101 manufactured by Viasys Respiratory Care Inc.
[711108]
The following description of the event was documented by a viasys tech support specialist in response to a phone conversation with a user facility representative. "customer states that they are always getting shocked when they are using the system. Replaced ever since getting shocked. "
Patient Sequence No: 1, Text Type: D, B5
[7860547]
The following information concerning the evaluation of the device by the user facility was documented by a viasys field service rep. In response to a phone conversation with a user facility representative. "unit only shocks by electrostatic. Bhiomed performed electrical safety, no problem found. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2007-00013 |
| MDR Report Key | 907188 |
| Report Source | 06 |
| Date Received | 2007-03-15 |
| Date of Report | 2007-03-15 |
| Date of Event | 2007-02-14 |
| Date Facility Aware | 2007-02-14 |
| Report Date | 2007-02-14 |
| Date Reported to Mfgr | 2007-02-14 |
| Date Mfgr Received | 2007-02-14 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2007-09-05 |
| 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 | JAMES STYTLE |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal | 92262 |
| Manufacturer Phone | 7608837120 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSORMEDICS |
| Generic Name | PULMONARY/METABOLIC SYSTEMS |
| Product Code | BZG |
| Date Received | 2007-03-15 |
| Model Number | VMAX ENCORE 29 |
| Catalog Number | 777408-101 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 881505 |
| Manufacturer | VIASYS RESPIRATORY CARE INC |
| Manufacturer Address | 1100 BIRD CENTER DRIVE PALM SPRINGS CA 92262 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-15 |