MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-31 for NEOPUFF INFANT RESUSCITATOR RD900 manufactured by Fisher & Paykel Healthcare Ltd.
[187894883]
(b)(4). Method:the subject rd900 neopuff infant resuscitator was returned to the fisher & paykel healthcare (f&p) in (b)(4) where it was visually inspected and performance checked by a trained f&p service technician. Results: inspection of the subject neopuff revealed that the manometer and valve was non operational. Conclusion: we are unable to determine what may have caused the reported event. 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 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". The neopuff is assembled and 100% tested on the production line to verify that each neopuff product conforms to critical product specifications. All neopuffs are visually inspected and performance tested prior to leaving the production line, and those that fail are rejected. It should be noted that the subject device is over 12 years old.
Patient Sequence No: 1, Text Type: N, H10
[187894884]
A healthcare facility in (b)(6) requested a routine service for a rd900 neopuff infant resuscitator. Upon device assessment at the fisher & paykel healthcare (f&p) regional office in (b)(4) on the 2nd of march 2020, it was found that manometer and valve were faulty. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00337 |
| MDR Report Key | 9908786 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2007-03-13 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4534000142 |
| 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 | 2020-03-31 |
| Model Number | RD900 |
| Catalog Number | RD900 |
| Lot Number | 070313 |
| 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 | 2020-03-31 |