MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-31 for WATER TRAP SINGLE USE RT032 manufactured by Fisher & Paykel Healthcare Limited.
[91230628]
(b)(4). Method: six rt032 single use water traps were received at fisher & paykel healthcare (b)(4) for evaluation. The returned water traps were visually inspected and tested for leaks via water bath testing. Results: visual inspection revealed that the returned water trap lids had been incorrectly re-attached, causing partial deformation of the water trap bowls at the sealing surface. It was also noted that the locking tabs of two water trap bowls had been broken off, resulting in a gap along the sealing surface. Additionally, the locking tabs show signs of wear indicative of multiple re-assemblies. Once the water trap lids were correctly re-attached for testing, the leak test confirmed that five of the six returned water traps were leaking from where the bowls had become deformed and/or where the sealing surface had been broken. Conclusion: based on the damage observed during investigation, it appears the leaking likely occurs during/after use when the user separates the lid and bowl to drain condensate and re-attaches them incorrectly, causing the bowl to deform and/or the locking tabs to break. All rt032 single use water traps are visually inspected during production to ensure that all locking tabs are fully engaged and the lid is in even contact with the water bowl sealing surface. This ensures that the lid and bowl align evenly along the circumference of the bowl and that the two surfaces sit flush with one another. Those that fail inspection are rejected. Our user instructions that accompany the rt032 state the following: - check connections and pressure test before use. - single use only.
Patient Sequence No: 1, Text Type: N, H10
[91230629]
A hospital in (b)(6) reported via our distributor that the rt032 single use water traps leak from the lid. This was reported to be found before patient use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2017-01011 |
| MDR Report Key | 6992546 |
| Date Received | 2017-10-31 |
| Date of Report | 2017-10-02 |
| Date Mfgr Received | 2017-10-02 |
| Date Added to Maude | 2017-10-31 |
| 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. SHARON KURUVILLA |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LIMITED |
| 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 | 0 |
| Brand Name | WATER TRAP SINGLE USE |
| Generic Name | BYH |
| Product Code | BYH |
| Date Received | 2017-10-31 |
| Returned To Mfg | 2017-10-19 |
| Model Number | RT032 |
| Catalog Number | RT032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-31 |