MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-08-06 for MX 8000 PHANTOM 47971801106 NA manufactured by Philips Medical Systems Tech/advanced Technology Center.
[21690334]
Hosp technician lifted qa phantom for mx8000 ct scanner with the left arm. Hosp tech used the appropriate handle for lifting. Hosp tech has a probable torn pectoral muscle and severely sprained bicep with total loss of motion of left arm and probably needs surgery to correct.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525965-2003-00008 |
| MDR Report Key | 476391 |
| Report Source | 05 |
| Date Received | 2003-08-06 |
| Date of Report | 2003-07-09 |
| Date of Event | 2003-07-07 |
| Date Mfgr Received | 2003-07-09 |
| Date Added to Maude | 2003-08-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL HAYES |
| Manufacturer Street | 595 MINER RD |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404833521 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS TECH |
| Manufacturer Street | MATAM, BLDG 3/1 PO BOX 325 |
| Manufacturer City | HAIFA 31004 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MX 8000 PHANTOM |
| Generic Name | RADIOGRAPHIC ANTHROPOMORPHIC PHANTOM |
| Product Code | IXG |
| Date Received | 2003-08-06 |
| Model Number | 47971801106 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 465218 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS TECH/ADVANCED TECHNOLOGY CENTER |
| Manufacturer Address | MATAM, BLDG 3/1 PO BOX 325 HAIFA IS 31004 |
| Baseline Brand Name | SYSTEM PHANTOM |
| Baseline Generic Name | RADIOGRAPHIC ANTHROPOMORPHIC PHANTOM |
| Baseline Model No | 47971801106 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-08-06 |