NEOPUFF INFANT RESUSCITATOR RD900

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number9611451-2020-00337
MDR Report Key9908786
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-31
Date of Report2020-02-11
Date of Event2020-02-11
Date Mfgr Received2020-03-02
Device Manufacturer Date2007-03-13
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS FARANAK GOMAROONI
Manufacturer Street173 TECHNOLOGY DRIVE SUITE 100
Manufacturer CityIRVINE, CA
Manufacturer CountryUS
Manufacturer Phone4534000142
Manufacturer G1FISHER & PAYKEL HEALTHCARE LTD
Manufacturer Street15 MAURICE PAYKEL PLACE EAST TAMAKI
Manufacturer CityAUCKLAND, 2013
Manufacturer CountryNZ
Manufacturer Postal Code2013
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEOPUFF INFANT RESUSCITATOR
Generic NameBTL
Product CodeBTL
Date Received2020-03-31
Model NumberRD900
Catalog NumberRD900
Lot Number070313
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFISHER & PAYKEL HEALTHCARE LTD
Manufacturer Address15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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