MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-07 for AIRFIT F30 SML SYS - AMER 64100 manufactured by Resmed Ltd.
[188543173]
Resmed has requested for the products to be returned so that an engineering investigation could be performed. The products have not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time. The reportable event occurred outside the us. During a routine check of complaints records it was detected that the event is reportable in the us. This report is being submitted to correct the error. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188543174]
It was reported to resmed that during use of airfit f30 full face masks, 'non-vented mask' alarms are occurring. It was reported visual inspection of the quiet air vent of the masks revealed blockage (hair, build-up, etc. ). There was no reported patient harm or an injury as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004604967-2020-00025 |
| MDR Report Key | 9560761 |
| Report Source | FOREIGN |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date Facility Aware | 2019-11-15 |
| Date Mfgr Received | 2019-11-15 |
| Date Added to Maude | 2020-01-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MICHELLE HUGHES |
| Manufacturer Street | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA |
| Manufacturer City | SYDNEY, NSW 2153 |
| Manufacturer Country | AU |
| Manufacturer Postal | 2153 |
| Manufacturer G1 | RESMED LTD |
| Manufacturer Street | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA |
| Manufacturer City | SYDNEY, NSW 2153 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 2153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRFIT F30 SML SYS - AMER |
| Product Code | BZD |
| Date Received | 2020-01-07 |
| Model Number | 64100 |
| Catalog Number | 64100 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD |
| Manufacturer Address | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA SYDNEY, NSW 2153 AU 2153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |