MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-01-19 for F&P SLEEPSTYLE AUTO CPAP SPSAAJ manufactured by Fisher & Paykel Healthcare Ltd.
[182588005]
(b)(4). We are currently in the process of evaluating the complaint f&p sleepstyle series cpap. We will provide a follow-up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10
[182588006]
A distributor in (b)(6) reported that an inlet pin from the main power inlet socket of an f&p sleepstyle auto cpap had broken. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00073 |
| MDR Report Key | 9604883 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-01-19 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2018-10-09 |
| Date Added to Maude | 2020-01-19 |
| 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 | MS. FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 8007923912 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F&P SLEEPSTYLE AUTO CPAP |
| Generic Name | BZD |
| Product Code | BZD |
| Date Received | 2020-01-19 |
| Model Number | SPSAAJ |
| Catalog Number | SPSAAJ |
| Lot Number | 2100605437 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-19 |