MAUDE Adverse Event Report: HUDSON MASK,HIGH CONC,ELONG,ADULT; MASK, OXYGEN

Model Number	IPN913881
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "the reservoir bag was not easily inflated during use.Therefore, the mask was replaced with a new one".No patient harm or consequence reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also conducted and no issues were encountered.The device functioned as intended.The complaint could not be confirmed as no issues were found with the returned device.
Event or Problem Description
It was reported that "the reservoir bag was not easily inflated during use.Therefore, the mask was replaced with a new one".No patient harm or consequence reported.Patient condition reported as "fine".

• Brand Name: HUDSON MASK,HIGH CONC,ELONG,ADULT
• Common Device Name: MASK, OXYGEN
• MDR Report Key: 11934818
• Report Number: 3004365956-2021-00186
• Device Sequence Number: 11720420
• Product Code: BYG
• UDI-Device Identifier: 14026704647986
• UDI-Public: 14026704647986
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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
• Operator of Device: No Information
• Device Expiration Date: 06/29/2025
• Device Model Number: IPN913881
• Device Catalogue Number: 1007
• Device Lot Number: 74F2001550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1