MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for DRX-REVOLUTION MOBILE X-RAY SYSTEM DRX-R-1 manufactured by Carestream Health, Inc.
[125639015]
An x-ray tech needed to position a portable x-ray unit above the patient. Prior to this, a radiant warmer that was providing therapy to the patient had to be repositioned away from above the patient to make room for the portable x-ray. The radiant warmer was moved away from above the patient, but not enough to clear the counterbalance of the x-ray unit. When the x-ray tech moved the collimator down toward the patient, the x-ray counterbalance moved up, raising the radiant warmer attached to the patient's bed. Eventually, the radiant warmer slipped off of the counterbalance and the bed drops to the ground. Approximately 4 or 5 inches. The x-ray technician did not move the radiant warmer arm, a nurse did. The x-ray unit has no indication that the counterbalance raises up in the air. That knowledge is only known by experience. This probably contributed to this event. No patient harm, but considering the acuity of the patient, this was truly a "near miss".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8023174 |
| MDR Report Key | 8023174 |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-10-28 |
| Report Date | 2018-10-29 |
| Date Reported to FDA | 2018-10-29 |
| Date Reported to Mfgr | 2018-10-31 |
| Date Added to Maude | 2018-10-31 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | DRX-REVOLUTION MOBILE X-RAY SYSTEM |
| Generic Name | SYSTEM, X-RAY, MOBILE |
| Product Code | IZL |
| Date Received | 2018-10-31 |
| Model Number | DRX-R-1 |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM HEALTH, INC |
| Manufacturer Address | 150 VERONA ST ROCHESTER NY 14608 US 14608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-31 |