MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-12 for FLOTEC manufactured by Flotec Inc..
[136599978]
Due to lack of contact information, we were unable to contact the reporting individual to obtain the unit in question for investigation. We would like to note that the ingage regulator is not intended as a life-sustaining device. We conducted an investigation on the manufacturing of our ingage regulators. The gauge functions by a moving measuring device attached to an outer decal ring which displays the pressure measurement. At the time of the reported incident, our manufacturing process relied on a purely mechanical connection between the measuring device and the decal. There existed the potential for the decal to become disconnected from the measuring device. If this occurs, the display would not change in response to pressure changes, and the reported device malfunction could occur. In our current manufacturing process, the decal is attached to the measuring device by a mechanical connection as well as an adhesive. This additional step in our manufacturing process greatly reduces the risk of the decal detaching from the measuring device and causing a failure mode similar to the reported incident.
Patient Sequence No: 1, Text Type: N, H10
[136599979]
This report is our response to report number mw5012641 with mdr report key (b)(4). That report was issued on 08/27/2009. Due to lack of contact information, we were unable to contact the reporting individual to obtain the unit in question for investigation. We would like to note that the ingage regulator is not intended as a life-sustaining device. We conducted an investigation on the manufacturing of our ingage regulators. The gauge functions by a moving measuring device attached to an outer decal ring which displays the pressure measurement. At the time of the reported incident, our manufacturing process relied on a purely mechanical connection between the measuring device and the decal. There existed the potential for the decal to become disconnected from the measuring device. If this occurs, the display would not change in response to pressure changes, and the reported device malfunction could occur. In our current manufacturing process, the decal is attached to the measuring device by a mechanical connection as well as an adhesive. This additional step in our manufacturing process greatly reduces the risk of the decal detaching from the measuring device and causing a failure mode similar to the reported incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832475-2019-00001 |
| MDR Report Key | 8333247 |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-12 |
| Date of Event | 2009-06-06 |
| Date Mfgr Received | 2018-06-23 |
| Date Added to Maude | 2019-02-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN PICHON |
| Manufacturer Street | 7625 WEST NEW YORK STREET |
| Manufacturer City | INDIANAPOLIS IN 46214 |
| Manufacturer Country | US |
| Manufacturer Postal | 46214 |
| Manufacturer Phone | 3172736960 |
| Manufacturer G1 | FLOTEC INC |
| Manufacturer Street | 7625 WEST NEW YORK STREET |
| Manufacturer City | INDIANAPOLIS IN 46214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46214 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLOTEC |
| Generic Name | INGAGE REGULATOR |
| Product Code | CAN |
| Date Received | 2019-02-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FLOTEC INC. |
| Manufacturer Address | 7625 WEST NEW YORK STREET INDIANAPOLIS IN 46214 US 46214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-12 |