MAUDE Adverse Event Report: UNOMEDICAL S.A DE C.V. MEDIUM CONCENTRATION MASK, ADULT, 2.1M; MASK, OXYGEN, NON-REBREATHING

Model Number PMD06104

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

Complaint reporting oxygen tubing seemed to be blocked on opening this meant no oxygen could flow through.Staff needed to open another pack.No further information was provided including patient outcome or usage of the device.

Manufacturer Narrative

The last three (3) product monitoring reviews (pmrs) were reviewed and none of the affected product codes have illustrated any trends for product category or any malfunction or any harm.More specifically, there were no trends observed for oxygen masks.Complaints spanning from october 27, 2014, through october 27, 2016 (2 years) were reviewed as it related to reports of nozzle issues.A total of three (3) complaints were reported from a single complaint.No trends were observed and no harms reported.In all cases, the product was discontinued and replaced.Complaints spanning from october 27, 2014, through october 27, 2016 (2 years) were reviewed as it related to reports of blocked oxygen tubing.A total of one (1) complaint was reported.No trends were observed and no harms reported.In all cases, the product was discontinued and replaced.These issues will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on january 13, 2017.

• Brand Name: MEDIUM CONCENTRATION MASK, ADULT, 2.1M
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): UNOMEDICAL S.A DE C.V.; av.:industrial falcon lote 7; parque ind, del norte; reynosa, tamaulipas 88736 ; MX 88736
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5984396
• MDR Text Key: 55883776
• Report Number: 9680866-2016-00089
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: PMD06104
• Device Lot Number: 118656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2016
• 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: Unknown
• Patient Sequence Number: 1