MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-02 for BUGBOX PLUS manufactured by Kinn Technology Lts..
[44581298]
Lab staff noted air or gas frequently compressing into chamber and concerned about hydrogen leak. Medical gas cylinder changed and checked for gas leak and found none. On further inspection of bugbox, staff found a white tubing on left side in chamber disconnected. Tube reconnected. Tube does not have clamp or other method of securing connectivity. Technical representative (b)(6) from bugbox contacted for support and trouble shooting. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062091 |
| MDR Report Key | 5633712 |
| Date Received | 2016-05-02 |
| Date of Report | 2016-05-02 |
| Date of Event | 2016-03-24 |
| Date Added to Maude | 2016-05-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BUGBOX PLUS |
| Generic Name | ANAEROBIC B OX |
| Product Code | JTM |
| Date Received | 2016-05-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KINN TECHNOLOGY LTS. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-02 |