MAUDE Adverse Event Report: NULL VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Device Problems Crack (1135); No Flow (2991); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

It was reported that the device was not giving any flow of air, it had a cracked case and it was noisy.No patient involvement was reported.

Manufacturer Narrative

Corrected data: product information was updated.

Manufacturer Narrative

Additional information added to h6 and h10.This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with a cracked top and bottom case, patient fitting, and momentary valve.Lever extension is crooked.Internal rattling is heard, top case damages were discovered as the rattling upon evaluation.Continuous cycling was found at the adult settings only/ top and bottom case contains damages/ rattling noise is consistent with broken casing found internally.The root cause of the reported issue was found to be a faulty timing valve assembly/ damage to the top and bottom case.Actions were taken to mitigate the reported issue: replaced timing valve assembly.

• Brand Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 13151405
• MDR Text Key: 286372605
• Report Number: 3012307300-2022-00025
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 04/20/2023; 04/20/2023
• Supplement Dates FDA Received: 02/28/2022; 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1