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

Model Number RD900

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rd900 neopuff infant resuscitator is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via our distributor that the button regulating the aspiration pressure of an rd900 neopuff infant resuscitator was out of order.A service of the device was requested.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint rd900 neopuff infant resuscitator was returned to our service centre in (b)(4) where it was inspected and performance tested by a trained fisher & paykel healthcare (fph) service technician.Our investigation is based on the service report provided by our (b)(4) office.Results: performance test of the complaint neopuff unit revealed that the reported fault could not be replicated with regards to the inspiratory pressure knob out of order.The unit passed all conducted performance tests.Conclusion: we were unable to determine what had caused the "button regulating the aspiration pressure being out of order" as reported by the customer as no fault was found with the complaint device provided.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".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 subject neopuff was returned to the customer after passing the safety and performance checks.

Event Description

A healthcare facility in (b)(6) reported via our distributor that the button regulating the aspiration pressure of an rd900 neopuff infant resuscitator was out of order.A service of the device was requested.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 ; 9194534000
• MDR Report Key: 5020408
• MDR Text Key: 24816469
• Report Number: 9611451-2015-00369
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K892885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• 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: 060829
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2006
• 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