MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-03 for NEOPUFF INFANT RESUSCITATOR RD900 manufactured by Fisher & Paykel Healthcare Ltd.
[182739111]
(b)(4). Method: the rd900 neopuff infant resuscitator was returned to the fisher & paykel healthcare (f&p) regional office in (b)(4), where it was inspected by a trained f&p service technician. Our investigation is based on the information and photographs provided by the f&p service technician. Visual inspection of the provided photographs were reviewed. Results: visual inspection of the photographs provided by the service technician were reviewed and inspection of the complaint neopuff resuscitator identified that the gas outlet port was damaged. Conclusion: we are unable to determine what may have caused the reported event to the subject neopuff resuscitator. The neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to an infant until adequate spontaneous breathing occurs. Being a portable device, the neopuff can be susceptible to damage, for instance when accidentally dropped or subjected to considerable external force. The neopuff technical manual states the following: dropping the neopuff / perivent infant resuscitator or other similar forms of impact may cause damage resulting in incorrect operation of the unit. If you suspect damage to have occurred, please perform checks as outlined [in the manual] before connection to a patient. In addition the neopuff user instructions state that the user should "check manometer reads zero with no gas flow" and check the pressure settings "prior to every use of the neopuff". Each neopuff unit is assembled and 100% tested in the production line to verify that each unit conforms to critical product specifications. Any unit that fails is rejected. The subject neopuff would have met the requirements at the time of production.
Patient Sequence No: 1, Text Type: N, H10
[182739112]
A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a rd900 neopuff infant resuscitator has a "broken/damaged patient outlet" port. Service was requested. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00225 |
| MDR Report Key | 9783345 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2007-10-24 |
| Date Added to Maude | 2020-03-03 |
| 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 | NEOPUFF INFANT RESUSCITATOR |
| Generic Name | BTL |
| Product Code | BTL |
| Date Received | 2020-03-03 |
| Model Number | RD900 |
| Catalog Number | RD900 |
| Lot Number | 071024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-03 |