MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-23 for DUO FLUID CART WITH SMOKE EVACUATOR - REFURBISHED UE514010200 manufactured by Dornoch.
[184538531]
(b)(4). The investigation and evaluation of the device is in process. Once the investigation is completed, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[184538532]
It has been reported that the unit had smoke coming from it, no power. The event timing was during cleaning. There was no harm to the patient. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001954182-2020-00018 |
| MDR Report Key | 9867964 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | DORNOCH |
| Manufacturer Street | 200 NORTHWEST PARKWAY |
| Manufacturer City | RIVERSIDE MO 64150 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64150 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUO FLUID CART WITH SMOKE EVACUATOR - REFURBISHED |
| Generic Name | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED |
| Product Code | JCX |
| Date Received | 2020-03-23 |
| Catalog Number | UE514010200 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNOCH |
| Manufacturer Address | 200 NORTHWEST PARKWAY RIVERSIDE MO 64150 US 64150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |