MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-21 for ERGOTRON 821086 COMPUTER CART manufactured by Ergotron.
[26270120]
Patient Sequence No: 1, Text Type: N, H10
[26270121]
A patient on a ventilator from the icu was transported to the mri suite by a respiratory therapist and a student nurse. The ventilator was mri safe, however, the cart that the vent was transported on was not. The ventilators are usually transported on the foot of the patient's bed, but in this case it was not. The non safe cart was inadvertently allowed to enter the zone 3 area. The zone 3 area is closely monitored by the mri staff so that no ferrous equipment enters zone 3. The patient remained in zone 2 and there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5090500 |
| MDR Report Key | 5090500 |
| Date Received | 2015-09-21 |
| Date of Report | 2014-08-19 |
| Date of Event | 2014-07-08 |
| Report Date | 2014-08-15 |
| Date Reported to FDA | 2014-08-15 |
| Date Reported to Mfgr | 2014-08-15 |
| Date Added to Maude | 2015-09-21 |
| 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 | PATIENT |
| 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 | ERGOTRON 821086 COMPUTER CART |
| Generic Name | COMPUTER CART |
| Product Code | LNX |
| Date Received | 2015-09-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERGOTRON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-21 |