MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-12-03 for ADULT HIGH CONCENTRATION REBREATHER , OXYGEN MASK 104-E manufactured by Unomedical S.a. De C.v..
[32635501]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. Additional patient/event details have been requested; however, no further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted. Expiration date: 08/2019. Device manufacture date: 08/2014. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32635502]
It was reported that the oxygen tubing disconnected from the mask's connector while in use on the patient. There was no adverse impact to the patient. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[34206005]
Additional information: a quality investigation was conducted to include a batch review and testing of retention samples of 104-e and no discrepancies were noted. A prior capa was leveraged for this complaint and has concluded that possible root causes for disconnection could be attributed to poor application of solvent that join the tube to mask connector and the inconsistency of manufacturing operators to follow assembly work instructions. Corrective action has been implemented. This complaint will be closed without further action. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680866-2015-00108 |
| MDR Report Key | 5265138 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-12-03 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-11-18 |
| Date Mfgr Received | 2015-12-14 |
| Date Added to Maude | 2015-12-03 |
| 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 | JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | CONVATEC, INC. |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT HIGH CONCENTRATION REBREATHER , OXYGEN MASK |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2015-12-03 |
| Model Number | 104-E |
| Lot Number | 105996 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL S.A. DE C.V. |
| Manufacturer Address | AV. INDUSTRIAL FALCON, LOTE 7 PARQUE IND. DEL NORTE REYNOSA, TAMAULIPAS 88736 MX 88736 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-03 |