MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-12-31 for MASK INTERFACE ADAPTOR RT013 manufactured by Fisher & Paykel Healthcare Ltd.
[182359777]
(b)(4). Method: the complaint rt013 adapters were not returned to fisher & paykel healthcare (f&p) for evaluation. Our investigation is thus based on the information and photo provided by the customer and our knowledge on the product. Results: visual inspection of the photo revealed that the tubing of the rt013 was found to be pulled apart near the circuit connector. Conclusion: from this information it appears that the reported issue is user related, rather than an inherent device failure. All rt013 mask interface adaptors are visually inspected for defects prior to leaving production. Those that fail this inspection are rejected. The user instructions which accompany the rt013 contain the following warning: do not crush or stretch tube.
Patient Sequence No: 1, Text Type: N, H10
[182359778]
A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher & paykel healthcare (f&p) representative that a tube of the rt013 interface adaptor was damaged. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2019-01265 |
| MDR Report Key | 9535021 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-12-31 |
| Date of Report | 2019-12-02 |
| Date Mfgr Received | 2019-12-02 |
| Device Manufacturer Date | 2019-06-18 |
| Date Added to Maude | 2019-12-31 |
| 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 | 9194534000 |
| 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 | MASK INTERFACE ADAPTOR |
| Generic Name | BZO |
| Product Code | BZO |
| Date Received | 2019-12-31 |
| Model Number | RT013 |
| Catalog Number | RT013 |
| Lot Number | 2100799515 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-12-31 |