MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-02-29 for COMPAX MODEL 40 45435245 manufactured by Ge Medical Systems, Llc.
[2492248]
It was reported that a hospital service engineer sustained a fracture of his left ring finger while servicing a compax model 40 table. The engineer was servicing the bucky and sensing cables in the table with the power off, when he moved the table longitudinally, his finger got jammed in the space between the table top and table frame. He sought medical attention immediately and a splint was applied to the broken finger. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
[9605592]
Service engineer age and weight were not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2012-00022 |
| MDR Report Key | 2476651 |
| Report Source | 99 |
| Date Received | 2012-02-29 |
| Date of Report | 2012-01-31 |
| Date of Event | 2012-01-26 |
| Date Mfgr Received | 2012-01-31 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 2012-03-06 |
| 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 | JOY SONSALLA |
| Manufacturer Street | 3000 N., GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPAX MODEL 40 |
| Generic Name | RADIOLOGIC TABLE |
| Product Code | IZZ |
| Date Received | 2012-02-29 |
| Model Number | 45435245 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-02-29 |