MAUDE Adverse Event Report: VYAIRE MEDICAL PRODUCT MASTERSCREEN PFT; CALCULATOR, PULMONARY FUNCTION DATA

Model Number MASTERSCREEN PFT

Device Problem Explosion (4006)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(6).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the oxygen regulator exploded.There was no patient involvement reported.

Manufacturer Narrative

"the most likely cause of the explosion would be due to a foreign substance that was inadvertently introduced into the o2 regulator.As the regulator was in use for approx.4 years before the accident took place, this could not have happened during production of the regulator and must be introduced later.The exact root cause for this could not be determined as all evidence of foreign substances were burnt during the fire.Due to the overall optical condition (scratches from tools, psa tape) and the fact that an adapter + ptfe tape was used, even though it is forbidden in the regulators ifu, points in the direction that the customer at least contributed to the event by insufficient handling/maintenance.This is the first incident ever reported to vyaire regarding any kind of exploded pressure reducer.The investigation does not indicate that the regulator itself was the source of failure.Nor did any information indicate that the masterscreen pft device malfunctioned and caused the incident.Therefore, the evaluation shows no need for any kind of corrective or preventive actions.The investigation documentation has been shared with the customer and coordination on preventing future misuse is in progress.".

• Brand Name: PRODUCT MASTERSCREEN PFT
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97201 ; GM 97201
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15524937
• MDR Text Key: 300986344
• Report Number: 9615102-2022-00128
• Device Sequence Number: 1
• Product Code: BZC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

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
• Device Model Number: MASTERSCREEN PFT
• Device Catalogue Number: MSDP
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 10/01/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1