MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for AMX-4 PLUS MOBILE X-RAY SYSTEM manufactured by Ge Medical Systems.
[141480665]
The digital portable machine was brought over to the ed room 1 for a portable chest x-ray. The machine would not take the xray (3 tries). The technologist had to go switch machines back in radiology in order to take the portable chest xray. This device was serviced by (b)(4). Problem description: install handswitch and cable. Work performed: installed replacement handswitch and cable. Tested unit for proper operation and obtained satisfactory results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8499894 |
| MDR Report Key | 8499894 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-02-14 |
| Report Date | 2019-02-21 |
| Date Reported to FDA | 2019-02-21 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMX-4 PLUS MOBILE X-RAY SYSTEM |
| Generic Name | SYSTEM, X-RAY, MOBILE |
| Product Code | IZL |
| Date Received | 2019-04-10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS |
| Manufacturer Address | 3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |