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

Model Number RD900

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rd900 neopuff infant resuscitator is currently enroute to fisher & paykel healthcare in (b)(4) for evaluation, to determine if it caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that a rd900 neopuff infant resuscitator unit is losing pressure.This issue was noticed during a preventative maintenance check and requested service.There was no patient involvement.

Event Description

A healthcare facility in iowa reported that a rd900 neopuff infant resuscitator unit is losing pressure.This issue was noticed during a preventative maintenance check and requested service.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: only the manometer of the complaint rd900 neopuff infant resuscitator was returned to fisher & paykel healthcare for investigation.No physical damage observed but the manometer was received with the needle indicating approximately -12cmh2o.The complaint manometer was adjusted to indicate 0cmh2o and fitted into a known good valve system and tested based on the neopuff technical manual.Results: the performance test revealed that the manometer of the subject neopuff was out of specification.Conclusion: it is most likely that the out of specification manometer was caused by some sort of impact to the neopuff.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 should be noted that the complaint device was more than twelve years old.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 unit was repaired and returned to the customer after passing all the necessary performance tests.

• 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
• MDR Report Key: 7760683
• MDR Text Key: 116400777
• Report Number: 9611451-2018-00667
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• PMA/PMN Number: K892885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• 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: 060710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1