MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-08-23 for SENSORMEDICS 41 OMEGA UNK manufactured by Viasys Respiratory Care Inc.
[20760269]
The following descriptions of the event were documented by a viasys tech support specialist in response to a phone conversation with a user facility representative. "[user facility rep. ] called and stated that the patient was "shocked" by the system during rem sleep. Then in the am patient stated that he was dreaming it. Stated it was his chest, neck and head that he felts the shock in. No power outages, generator tests, or electrical storms were noted during the test. No computer crashes or other incidents occurred during the study itself. Isolation transformer is in use. This is an old omega 24 system where the amp is powered from the internal board in the computer. Rep would like a call back from a supervisor and to speak with an engineer to discern whether this could have actually happened. " "patient was sleeping and having a dream, the patient called out to the tech and stated that they got shocked to the head, neck and chest. The tech asked if he was dreaming this and he said no, but she couldn't be sure he wasn't. "
Patient Sequence No: 1, Text Type: D, B5
[20820905]
A letter was sent via fax to the user facility requesting additional information concerning the reported event and the condition of the patient. As of the date of this report there has been no response from the user facility. The user facility did not submit a user facility report to the manufacturer. Event codes were derived based on information documented by a viasys tech support specialist in response to a phone conversation with a user facility representative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2007-00050 |
| MDR Report Key | 901327 |
| Report Source | 06 |
| Date Received | 2007-08-23 |
| Date of Report | 2007-08-23 |
| Date of Event | 2007-07-24 |
| Date Facility Aware | 2007-07-24 |
| Date Mfgr Received | 2007-07-24 |
| Device Manufacturer Date | 2000-06-07 |
| Date Added to Maude | 2007-08-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES STYTLE |
| Manufacturer Street | 1100 BIRD CENTER DR. |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal | 92262 |
| Manufacturer Phone | 7608837120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSORMEDICS |
| Generic Name | SLEEP ANALYSIS SYSTEM |
| Product Code | BZC |
| Date Received | 2007-08-23 |
| Model Number | 41 OMEGA |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 878115 |
| Manufacturer | VIASYS RESPIRATORY CARE INC |
| Manufacturer Address | 1100 BIRD CENTER DR. PALM SPRINGS CA 92262 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-23 |