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.
[117287727]
Field correction 1419185-7/24/18-001-c has been initiated for correction of other potentially afftected devices.
Patient Sequence No: 1, Text Type: N, H10
[117287728]
On (b)(6) 2018 a complaint was received for the care-e-vac 3 device in which the customer stated "unit was smoking and had to clear out the unit from room located, he found burnt wires and burnt marks inside the unit". Customer was contacted on 4/11/2018 to obtain additional information. It was stated by mr. (b)(6) that he received a call about smoke detected on a patient floor. The area was evacuated because it could not be determined where the smoke was coming from. Mr. (b)(6) removed 3 different portable devices and brought them to the bio-med area for further investigation, and area was then allowed to be used. While in the biomed area the care-e-vac 3 device was opened up and it was then noted that insulation on wires had melted. It was stated by mr. (b)(6) that the device was being stored (not in use) on the department code cart when smoke smell was noted, and that the last time the device was verified to be in working order was sometime during february 2018. Upon return to the manufacturer on 04/23/2018 the following was noted by the repair technician "due to extent of damage, unit is beyond economical repair (ber). " a replacement device was sent to the customer. It was determined by engineering that the device may have been contaminated during storage on the code cart and no further actions were necessary. Device was retained by engineering. On 6/22/2018 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 melted wires.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419185-2018-00004 |
| MDR Report Key | 7771090 |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-09 |
| Date Mfgr Received | 2018-06-22 |
| Device Manufacturer Date | 2018-01-27 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2018-04-23 |
| Model Number | 758000 |
| Catalog Number | 758000 |
| Lot Number | CEB181003 |
| 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 |