MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-31 for CARE-E-VAC 3 758000 manufactured by Ohio Medical Llc.
[46918993]
Patient Sequence No: 1, Text Type: N, H10
[46918994]
Ohio medical received customer complaint for portable suction device on march 31, 2016 stating "burn spot on board". Device was received by manufacturer on 4/13/2016, it was noted on 4/19/2016 that board (power supply) did in fact exhibit damage. Upon further evaluation, it was noted that device was contaminated by fluid ingress. It is suspected that fluid came into contact with power supply component, causing the burn/ damage. Ohio medical service manual states the following: page 5, processing & cleaning section 2. "do not allow any cleaning solution to spill into the vents on the unit. " and page 7 d) warning: decontamination 4. B. "items that must be replaced if exposed to fluids and contaminates: tubing, control circuit, power supply, pump, switch. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419185-2016-00026 |
| MDR Report Key | 5689896 |
| Date Received | 2016-05-31 |
| Date of Report | 2016-04-29 |
| Date of Event | 2016-03-31 |
| Date Mfgr Received | 2016-03-31 |
| Date Added to Maude | 2016-05-31 |
| 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 | 2016-05-31 |
| Returned To Mfg | 2016-04-13 |
| Model Number | 758000 |
| Catalog Number | 758000 |
| Lot Number | CEB141017 |
| 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 | 2016-05-31 |