MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-08 for CARE-E-VAC 3 758000 manufactured by Ohio Medical Llc.
[117003167]
Field correction 1419185-7/24/18-001-c has been initiated for correction of other potentially affected devices.
Patient Sequence No: 1, Text Type: N, H10
[117003168]
On 11/15/2017 a complaint was received for the care-e-vac 3 device in which the customer stated "out of box failure". Upon return to the manufacturer on 12/7/2017 the following was noted by the repair technician " note: this is not an out of box failure. Evidence of extensive use and seal broken indicating unit has been opened. Inspection in repair center shows this unit had liquid damage causing catastrophic electrical failure. " pictures were provided that show melted wires from the device battery to the pc board. Device was retained by engineering. On (b)(6) 2018 there was an occurence in house during assembly of the care-e-vac 3 device in which same time of effect occured (melted wires leading from battery to the pc board). Ship hold was initiated immediately and investigation began looking further into the cause of the burning/ melted wires. This device was re-evaluated by engineering with comparison to failure which occured in house. Same effects of failure were observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419185-2018-00002 |
| MDR Report Key | 7765710 |
| Date Received | 2018-08-08 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-06-22 |
| Device Manufacturer Date | 2017-06-16 |
| Date Added to Maude | 2018-08-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JESSICA BARRILE |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8478556318 |
| Manufacturer G1 | OHIO MEDICAL LLC |
| Manufacturer Street | 1111 LAKESIDE DR |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARE-E-VAC 3 |
| Generic Name | PORTABLE SUCTION DEVICE |
| Product Code | BTA |
| Date Received | 2018-08-08 |
| Returned To Mfg | 2017-12-07 |
| Model Number | 758000 |
| Catalog Number | 758000 |
| Lot Number | CEB171029 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL LLC |
| Manufacturer Address | 1111 LAKESIDE DR GURNEE IL 600312489 US 600312489 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-08 |