MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD NEOPUFF INFANT RESUSCITATOR; BTL

Model Number RD900

Device Problem False Device Output (1226)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) please note this report was submitted on 18 february 2016 but due to an error with the fda gateway the three acknowledgements were not received.This report is being submitted again upon recommendation from the cdrh.The complaint device was recently returned to our office in (b)(4), for inspection.Our investigation is currently in progress and we will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6), reported that an rd900 neopuff infant resuscitator does not read the correct pressure.They further reported that there was physical damage to the device.No patient consequence was reported.

Manufacturer Narrative

Method: the complaint rd900 infant resuscitator was returned to our service center in irvine, california, where it was visually inspected and performance tested.Results: visual inspection revealed cracks on the enclosure on the upper and lower end caps.Cracks were also noted on the fascia and valve assembly.Performance test revealed that the manometer was faulty.A lot check revealed no other complaints of this nature for lot 070816.Conclusion: the neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to infants until adequate spontaneous breathing occurs.Being a portable device, the neopuff can be susceptible to impact damage, for instance when accidentally dropped or subjected to considerable external force.It must be noted that the subject neopuff is over eight years old.All neopuff units are visually inspected and performance tested prior to leaving the production line, and those that fail are rejected.The neopuff technical manual warns against dropping the neopuff or subjecting it to impact damage which may cause the unit to operate incorrectly.If the neopuff is suspected to have been damaged, the manometer and valve system should be performance tested.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".

Event Description

A healthcare facility in (b)(6), reported that an rd900 neopuff infant resuscitator does not read the correct pressure.They further reported that there was physical damage to the device.No patient consequence was reported.

• Brand Name: NEOPUFF INFANT RESUSCITATOR
• Type of Device: BTL
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5465705
• MDR Text Key: 39208245
• Report Number: 9611451-2016-00062
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RD900
• Device Catalogue Number: RD900
• Device Lot Number: 070816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1