MAUDE Adverse Event Report: HUDSON RESUS NEO MANOMETER AND MASK; VENTILATOR, EMERGENCY, MANUAL

Catalog Number 45372

Device Problem Unintended Deflation (4061)

Patient Problem Cardiac Arrest (1762)

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "during resuscitation of patient while transporting to icu.Firstly the mask of the bvm did not have enough air in it and the dr could not get a proper seal around the patients mouth and nose.Secondly the mask with the connectors connecting it to the bag itself came loose more than once during the resuscitations.Clinical consequences: they used a second resuscitator and that work well.No harm or delay caused for patient".Patient condition reported as "fine".

Event Description

It was reported "during resuscitation of patient while transporting to icu.Firstly the mask of the bvm did not have enough air in it and the dr could not get a proper seal around the patients mouth and nose.Secondly the mask with the connectors connecting it to the bag itself came loose more than ones during the resuscitations.Clinical consequences: they used a second resuscitator and that work well.No harm or delay caused for patient".Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HUDSON RESUS NEO MANOMETER AND MASK
• Type of Device: VENTILATOR, EMERGENCY, MANUAL
• MDR Report Key: 11869696
• MDR Text Key: 253526580
• Report Number: 3011137372-2021-00136
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K964719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 45372
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1