MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-03 for BIO-MED DEVICES 2003FFB manufactured by Bio-med Devices.
[59459970]
Manufacturer verified the observations of the hospital's own clinical engineering technicians ("knob damaged, shaft bent"). The face of the device had been significantly impacted, probably from a drop onto a hard floor. The control knob was cracked. The metal control shaft underneath was bent. The knob could not be actuated in a proper circular motion, instead it turned noticeably askew, with contact with the face plate interfering at some rotation points. The manufacturer repaired the device by replacing the control knob, and the entire underlying valve / shaft assembly, then re-calibrating the device.
Patient Sequence No: 1, Text Type: N, H10
[59459971]
Blender was pulled out of service when it was determined that the oxygen % output did not match knob set. Hospital clinical engineering found the knob damaged, with shaft bent. Blender was returned to mfr for repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218704-2016-00004 |
| MDR Report Key | 6075988 |
| Date Received | 2016-11-03 |
| Date of Report | 2016-11-01 |
| Date of Event | 2016-10-06 |
| Date Mfgr Received | 2016-10-06 |
| Device Manufacturer Date | 2009-10-06 |
| Date Added to Maude | 2016-11-03 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEN CLOSE |
| Manufacturer Street | 61 SOUNDVIEW RD |
| Manufacturer City | GUILFORD CT 06437 |
| Manufacturer Country | US |
| Manufacturer Postal | 06437 |
| Manufacturer Phone | 2034580202 |
| Manufacturer G1 | BIO-MED DEVICES |
| Manufacturer Street | 61 SOUNDVIEW RD |
| Manufacturer City | GUILFORD CT 06437 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIO-MED DEVICES |
| Generic Name | AIR / OXYGEN BLENDER |
| Product Code | MOD |
| Date Received | 2016-11-03 |
| Returned To Mfg | 2016-10-11 |
| Model Number | 2003FFB |
| Catalog Number | 2003FFB |
| Operator | RESPIRATORY THERAPIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-MED DEVICES |
| Manufacturer Address | 61 SOUNDVIEW RD GUILFORD CT 06437 US 06437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-03 |