MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-09 for CARE-E-VAC 3 758000 manufactured by Ohio Medical Llc.
[117140269]
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
[117140270]
On (b)(6) 2018 a complaint was received for the care-e-vac 3 device in which the customer stated "one of the units looks damaged/ used". The device was returned on 06/21/2018 and a replacement device was sent to the customer. On (b)(6) 2018 there was an occurrence in house during assembly of the care-e-vac 3 device in which same time of effect occurred (melted wires leading from battery to the pc board). Ship hold was initiated immediately and investigation began looking further into the cause of the melted wires.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419185-2018-00005 |
| MDR Report Key | 7771116 |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-09 |
| Date Mfgr Received | 2018-06-22 |
| Device Manufacturer Date | 2018-05-04 |
| Date Added to Maude | 2018-08-09 |
| 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 | 2018-08-09 |
| Returned To Mfg | 2018-06-21 |
| Model Number | 758000 |
| Catalog Number | 758000 |
| Lot Number | CEV318015 |
| 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 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-09 |