MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-12-11 for OBSOLETE S9 AUTOSET - RMD HC 36125 manufactured by Resmed Ltd.
[170421987]
Resmed has requested for the device to be returned so that an engineering investigation could be performed. The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[170421988]
It was reported to resmed that a patient's oxygen saturation decreases to 84% during use of an s9 autoset device with supplemental oxygen. It was reported the patient's oxygen saturation did not decrease when placed on supplemental oxygen without the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004604967-2019-00450 |
| MDR Report Key | 9454888 |
| Report Source | FOREIGN |
| Date Received | 2019-12-11 |
| Date of Report | 2020-03-06 |
| Date Facility Aware | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2019-12-11 |
| 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 | 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 | OBSOLETE S9 AUTOSET - RMD HC |
| Product Code | BZD |
| Date Received | 2019-12-11 |
| Model Number | 36125 |
| Catalog Number | 36125 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-12-11 |