MAUDE Adverse Event Report: VYAIRE MEDICAL MASTERSCREEN BODY/DIFF; CALCULATOR, PULMONARY FUNCTION DATA, PRODUCT CODE

Model Number MASTERSCR BODY/DIFF

Device Problems Mechanical Problem (1384); Intermittent Communication Failure (4038)

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

Event Date 03/16/2023

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).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 ms body diff analyzer had an electrical smell similar to a burn.It was then noticed that the device was getting hot/very warm to touch.This event has no patient involvement and was noted that no one was injured.

Manufacturer Narrative

H6, h7, h8 the investigation concluded, that most likely the defective pcb resulted in the cooling fan not turning, causing the analyzer getting hot.The possibility that a patient/user touches hot parts is mitigated through a housing made of plastic and/or metal.The risk results in a severity of harm of 3 (brief, but more perceptible effect for the patient or other persons but without serious effects).After investigation the reportability changes to not reportable.It is unlikely that the reoccurrence of the malfunction causes or contributes to a death or serious injury.G1, h3.

• Brand Name: MASTERSCREEN BODY/DIFF
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA, PRODUCT CODE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97201 ; GM 97201
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg, CA 97204 ; GM 97204
• MDR Report Key: 16710090
• MDR Text Key: 313021845
• Report Number: 9615102-2023-00133
• Device Sequence Number: 1
• Product Code: BZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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
• Device Model Number: MASTERSCR BODY/DIFF
• Device Catalogue Number: 175402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1