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 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint (b)(4) neopuff infant resuscitator was returned to the f&p service center in (b)(4) where it was inspected by a trained f&p service technician.Our investigation is based on the service report and photograph provided by the f&p service technician.Results: the photograph showed that the peak inspiratory pressure (pip) valve's adjustment knob was broken.Conclusion: 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 can be susceptible to damage, for instance when accidentally dropped or subjected to considerable external force.The physical damage observed was most likely due to impact to the subject neopuff unit.It must also be noted that the subject neopuff is 15 years old.The neopuff technical manual states the following: "dropping the neopuff 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".Each neopuff unit is assembled and 100% tested in the production line to verify that each unit conforms to critical product specifications.Any unit that fails is rejected.The subject neopuff unit was repaired and returned to the hospital after passing the performance tests specified on the neopuff technical manual.

Event Description

A hospital in (b)(6) reported that the peak inspiratory knob of a neopuff infant resuscitator was missing and the maximum pressure relief valve cover was broken.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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 7543589
• MDR Text Key: 109517299
• Report Number: 9611451-2018-00441
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• 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: 030213
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2003
• 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