MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for APNEALINK AIR-SERVICE DEVICE 19897 manufactured by Resmed Ltd.
[145380368]
The device was returned to resmed for an engineering investigation. The investigation methods, results, and conclusion are not finalized at this stage. When more information is available a supplemental report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145380369]
It was reported to resmed that a technician sustained a burn when removing the battery from an apnealink air device. There was no patient harm or serious injury reported as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004604967-2019-00162 |
| MDR Report Key | 8617916 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date Facility Aware | 2019-04-23 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-16 |
| 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. ARIANA BECK |
| Manufacturer Street | 9001 SPECTRUM CENTER BLVD |
| Manufacturer City | SAN DIEGO CA 92123 |
| Manufacturer Country | US |
| Manufacturer Postal | 92123 |
| Manufacturer G1 | RESMED CORP |
| Manufacturer Street | 9001 SPECTRUM CENTER BLVD |
| Manufacturer City | SAN DIEGO CA 92123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APNEALINK AIR-SERVICE DEVICE |
| Product Code | MNR |
| Date Received | 2019-05-16 |
| Returned To Mfg | 2019-05-08 |
| Model Number | 19897 |
| Catalog Number | 19897 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 6 MO |
| 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 | 2019-05-16 |