MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-06-22 for OMEGA 2000 MEG SYSTEM manufactured by Ctf System 2001 Inc., A Subsidiary Of Vsm Medtech Ltd..
[2767759]
A user of the device reported that while trying to raise the subject into the meg helmet the pt support (chair) continued to rise outside of the operator's control, stopping only when it reached its maximum height against the dewar. The user confirmed that the subject was able to get out of the chair uninjured but expressed concern of potential injury if s/he had not been able to out before the chair got too high.
Patient Sequence No: 1, Text Type: D, B5
[10116497]
(b)(4) the entity reporting this event, provides maintenance service and support for this device. Although not the mfr, (b)(4) has made aware of this event and has sent an initial notification to all other known users of similar equipment. (b)(4) will investigate and offer to rectify the problem at other potentially affected equipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616854-2012-00001 |
| MDR Report Key | 2632732 |
| Report Source | 06 |
| Date Received | 2012-06-22 |
| Date of Report | 2012-06-18 |
| Date of Event | 2012-06-18 |
| Date Mfgr Received | 2012-06-18 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2012-10-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIM BAIRD, GENERAL MGR. |
| Manufacturer Phone | 5406044 |
| Manufacturer G1 | MEG INTERNATIONAL SERVICE LTD. |
| Manufacturer Street | #1 - 850 HARTLEY AVENUE |
| Manufacturer City | COQUITLAM, BC V3K7A1 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | V3K 7A1 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMEGA 2000 MEG SYSTEM |
| Generic Name | MAGNETOENCEPHALOGRAPH |
| Product Code | OLY |
| Date Received | 2012-06-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CTF SYSTEM 2001 INC., A SUBSIDIARY OF VSM MEDTECH LTD. |
| Manufacturer Address | PORT COQUITLAM, BC CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-22 |