MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-08-21 for COMPAX 40E 46-182866G2 manufactured by Ge Medical Systems, Llc (hq).
[1237446]
While a healthcare professional (hcp) was positioning the collimator, it reportedly detached from suspension. Since the hcp was holding the handles, the collimator did not fall and come in contact with the patient. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8368002]
Ge field engineer (fe) was dispatched to the site and evaluated the system. After inspection, the fe found that the screws that held the collimator in place had come loose. No screws were missing. According to the fe, the system has not been under a ge service contract for several years. The state of the system suggested that the system had not been properly maintained. The fe reattached the collimator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2009-00041 |
| MDR Report Key | 1492026 |
| Report Source | 05 |
| Date Received | 2009-08-21 |
| Date of Report | 2009-07-24 |
| Date of Event | 2009-07-24 |
| Report Date | 2009-07-24 |
| Date Mfgr Received | 2009-07-24 |
| Device Manufacturer Date | 1993-12-01 |
| Date Added to Maude | 2010-06-14 |
| 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 | MARTHA KAMROW |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC (HQ) |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPAX 40E |
| Product Code | IZZ |
| Date Received | 2009-08-21 |
| Model Number | 46-182866G2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC (HQ) |
| Manufacturer Address | 3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-21 |