MAUDE Adverse Event Report: VYAIRE MEDICAL SPIROMETER VOLUME INCENTIVE 4000ML 12/CS; SPIROMETER, THERAPEUTIC (INCENTIVE)

Catalog Number	001902A
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.(b)(4).Sample was returned for evaluation.A follow up emdr will be submitted upon completion of the investigation.
Event or Problem Description
A customer contacted vyaire medical to report an incident with the spirometers where a patient inhaled a piece of plastic.Customer described the inhaled pieces as two pieces of 2 mm squares that were soft/pliable looking at the spirometer and measuring near where the mouthpiece gets attached to.There was only one patient harm indicated.The customer explained that the patient had coughed-up two small pieces of plastic into a kleenex.The reported incident happened when the patient was using the is pre-operatively as part of pre-op education.This was the first time used.There was no delay in crucial therapy as a result of the reported issue, as the patient was "bronched" prior to her scheduled procedure to ensure there were no airway issues.There patient was no harm.The kleenex was inadvertently thrown away, so the two actual pieces of plastic were not available.The rn described the pieces as small little squares that, when the engineer measured, were the same size as the is squares.
Additional Manufacturer Narrative
Additional information: e4, g3 device evaluation: g4, h2, h3, h6, h10 results of investigation: the sample was fully evaluated but no failure was detected.The reported issue could not be duplicated, so no root cause was could be determined.

• Brand Name: SPIROMETER VOLUME INCENTIVE 4000ML 12/CS
• Common Device Name: SPIROMETER, THERAPEUTIC (INCENTIVE)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9112912
• Report Number: 3003799815-2019-00001
• Device Sequence Number: 10706128
• Product Code: BWF
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K791819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 001902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other