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.
[47299733]
Patient Sequence No: 1, Text Type: N, H10
[47299734]
A user facility called on (b)(6) 2015 and requested return of device but did not specify the problem. There was no patient involvement, and the incident did not result in a delay of treatment. The device was evaluated on 07/02/2015 and it was noted that the device had a battery that would not hold a charge. Our risk document classifies the severity of a damaged diaphragm as "potentially requiring medical intervention to prevent permanent impairment of a body function or permanent damage to a body structure". We are obtaining further clinical evaluation of the risk of this failure and will provide follow up to this report once obtained.
Patient Sequence No: 1, Text Type: D, B5
[47343013]
Clinical assessment of the failure mode "dead battery" has been obtained and it has been determined that this occurence does not represent a reportable malfunction due to no evidence existing to reasonably suggest that the malfunction would be likely to cause or contribute to death or serious injury if it were to recur.
Patient Sequence No: 1, Text Type: N, H10
[47343014]
Clinical assessment of the failure mode "dead battery" has been obtained and it has been determined that this occurence does not represent a reportable malfunction due to no evidence existing to reasonably suggest that the malfunction would be likely to cause or contribute to death or serious injury if it were to recur.
Patient Sequence No: 1, Text Type: D, B5
[47981867]
This report is a correction to original report submitted on 01/29/2016: a user facility called on 06/02/2015 and requested return of device but did not specify the problem. There was no patient involvement, and the incident did not result in a delay of treatment. The device was evaluated on 07/02/2015 and it was noted that the device had a battery that would not hold a charge. Initial review of the complaint deemed the incident as not reportable because the failure mode was not considered to be likely to cause a serious injury or death should it recur. An external review of the complaint and the risk management documentation identified this complaint as reportable based on our risk assessment which classifies the severity of "dead battery" as "complete loss of performance, may result in permanent impairment or serious injury or death. " we are obtaining further clinical assessment of the risk of this failure mode as well as evaluating the risk management documentation and will provide follow up to this report once the assessment is completed.
Patient Sequence No: 1, Text Type: N, H10
[47981868]
This report is a correction to original report submitted on 01/29/2016: a user facility called on 06/02/2015 and requested return of device but did not specify the problem. There was no patient involvement, and the incident did not result in a delay of treatment. The device was evaluated on 07/02/2015 and it was noted that the device had a battery that would not hold a charge. Initial review of the complaint deemed the incident as not reportable because the failure mode was not considered to be likely to cause a serious injury or death should it recur. An external review of the complaint and the risk management documentation identified this complaint as reportable based on our risk assessment which classifies the severity of "dead battery" as "complete loss of performance, may result in permanent impairment or serious injury or death. " we are obtaining further clinical assessment of the risk of this failure mode as well as evaluating the risk management documentation and will provide follow up to this report once the assessment is completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419185-2016-00016 |
| MDR Report Key | 5689716 |
| Date Received | 2016-05-31 |
| Date of Report | 2016-05-31 |
| Date of Event | 2015-07-02 |
| Date Mfgr Received | 2015-06-02 |
| Device Manufacturer Date | 2007-06-13 |
| 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 |
| 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 | 3 |
| Brand Name | CARE-E-VAC 3 |
| Generic Name | PORTABLE SUCTION DEVICE |
| Product Code | BTA |
| Date Received | 2016-05-31 |
| Returned To Mfg | 2015-06-09 |
| Model Number | 758000 |
| Catalog Number | 758000 |
| Lot Number | CEB071055 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL |
| Manufacturer Address | 1111 LAKESIDE DR GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-31 |