MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-19 for COMPAX 40E 45435245 NA manufactured by Ge Medical Systems, Llc.
[21384222]
During a routine exam, a site technologist was positioning the collimator over a patient when the collimator fell and contacted the patient's face. According to the site, the patient required 15 stitches on his face. A ct scan was performed on the patient, and found no skeletal damage.
Patient Sequence No: 1, Text Type: D, B5
[21481773]
Ge field engineers (fe) were dispatched to the site and evaluated the system. The fes found 3 missing interface screws. The screws were then installed. The fes verified that the reported condition was fixed. Further investigation revealed that the site is not under a ge service contract. Ge performed the last preventative maintenance 1 year prior to the incident. In 2008, ge replaced the tube. However, there was no record that the site requested for the 6-month preventative maintenance service from ge as required after the replacement. Additionally, it was reported that the site had damaged the collimator later in the year. Ge provided a quote for a new collimator but the site decided to tape the damaged part. No further information was received from the site regarding how the collimator was impacted after they had fixed the damaged part. Multiple attempts were made by ge to obtain patient information. No response has been received from the site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2009-00019 |
| MDR Report Key | 1346910 |
| Report Source | 05 |
| Date Received | 2009-03-19 |
| Date of Report | 2009-02-23 |
| Date of Event | 2009-02-21 |
| Date Mfgr Received | 2009-02-23 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 2009-03-25 |
| 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 | BIOMEDICAL ENGINEER |
| 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. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC |
| 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 | 2009-03-19 |
| Model Number | 45435245 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| 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 |
| Manufacturer Address | 3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-03-19 |