MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-12-09 for APNEALINK BASIC SET US 22302 manufactured by Resmed Ltd.
[33097844]
The device has not been returned to the manufacturer, therefore, resmed is unable to determine at this time if the incident was caused by the alleged malfunction. Resmed is in communication with the reporter to obtain additional information regarding event details and has requested the unit be returned so that an extensive engineering investigation can be performed. Once the device is returned and the investigation is completed, resmed will provide a follow-up report with additional information. Resmed reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33097865]
It was reported to resmed that an apnealink home sleep testing device allegedly malfunctioned causing first degree burns to the user's abdomen.
Patient Sequence No: 1, Text Type: D, B5
[71373216]
The device was not returned to resmed for investigation. Pictures of the device and patient burns were provided to resmed, therefore, the complaint could be confirmed. An extensive engineering investigation was performed on the pictures. Review of the pictures provided to resmed revealed that the device was used with batteries with greater voltage than specified in the resmed clinical manual. Based on the information available, the investigation determined that the reported event was most likely due a short circuit of the batteries used with the device. The apnealink device does not contain a built in power source. Power requirements are defined in the clinical manual. Resmed's risk analysis for this failure mode concludes that the risk is acceptable. Note: during an audit of the complaint records, it was found that a follow-up report is required as new information is available. This report is submitted to address the reportable event. Resmed reference#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004604967-2015-00691 |
| MDR Report Key | 5283294 |
| Report Source | OTHER |
| Date Received | 2015-12-09 |
| Date of Report | 2017-03-23 |
| Date of Event | 2015-04-20 |
| Date Facility Aware | 2016-08-23 |
| Date Mfgr Received | 2016-08-23 |
| Device Manufacturer Date | 2007-06-18 |
| Date Added to Maude | 2015-12-09 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DULEY |
| Manufacturer Street | 9001 SPECTRUM CENTER BLVD |
| Manufacturer City | SAN DIEGO CA 92123 |
| Manufacturer Country | US |
| Manufacturer Postal | 92123 |
| Manufacturer Phone | 8588365985 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APNEALINK BASIC SET US |
| Generic Name | VENTILATORY EFFORT RECORDER |
| Product Code | MNR |
| Date Received | 2015-12-09 |
| Model Number | 22302 |
| Catalog Number | 22302 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD |
| Manufacturer Address | 1 ELIZABETH MACARTHUR DRIVE BELLA VISTA, NSW 2153 AS 2153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-09 |