MAUDE Adverse Event Report: WESTMED LLC HYPERINFLATION; DISPOSABLE HYPERINFLATION SYSTEM, 1/2L BREATHING BAG (LATEX FREE), 7' O2 AND MAN

Model Number	7-N7905-I-MAN
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manometers within the disposable hyperinflation system have become dysfunctional.The result required the clinician to switch bags and caused a delay in ventilation.
Event or Problem Description
The manometers within our disposable hyperinflation system have become dysfunctional. possible delay in ventilation.
Additional Manufacturer Narrative
The manometers within the disposable hyperinflation system have become dysfunctional.The result required the clinician to switch bags and caused a delay in ventilation.No images or returned product.However, the complaint filed has occurred from the same customer previously, and this issue of the broke manometers has occurred before (as stated in the email).Complaint not confirmed.This issue since the last complaint has been corrected and new drawings have been in place to prevent this issue.Per the dhr, no manometers were pulled during inspection.During sample testing all samples passed as well as the visual & functional inspection.No nc's attached.There are 29 units available from this lot.However, 11 units have been returned for a separate complaint/issue (old product that has since been updated).For the hyperinflation system fmean-20020e was referenced.In section 010, on page 14, third line up from the next section, it states "damaged components", "failed product with final user", "damaged components during the transportation" or "damaged components during the storage", "check by damaged components during the receiving.Inspect the components during the incoming inspection with the proper documents", s=7, o=1, d=4, rpn=28, rc=1.Likely causation was that the product was damaged in transit.Product passed inspections during production.
Event or Problem Description
The manometers within our disposable hyperinflation system have become dysfunctional. possible delay in ventilation.
Event or Problem Description
The manometers within our disposable hyperinflation system have become dysfunctional.Possible delay in ventilation.
Additional Manufacturer Narrative
The manometers within the disposable hyperinflation system have become dysfunctional.The result required the clinician to switch bags and caused a delay in ventilation.No images or returned product.However, the complaint filed has occurred from the same customer previously, and this issue of the broke manometers has occurred before (as stated in the email).Complaint not confirmed.This issue since the last complaint has been corrected and new drawings have been in place to prevent this issue.Per the dhr, no manometers were pulled during inspection.During sample testing all samples passed as well as the visual & functional inspection.No nc's attached.There are (b)(4) units available from this lot.However, 11 units have been returned for a separate complaint/issue (old product that has since been updated).For the hyperinflation system fmean-20020e was referenced.In section 010, on page 14, third line up from the next section, it states "damaged components", "failed product with final user", "damaged components during the transportation" or "damaged components during the storage", "check by damaged components during the receiving.Inspect the components during the incoming inspection with the proper documents", s=7, o=1, d=4, rpn=28, rc=1.Likely causation was that the product was damaged in transit.Product passed inspections during production.**udi related data quality updates only**.

• Brand Name: HYPERINFLATION
• Common Device Name: DISPOSABLE HYPERINFLATION SYSTEM, 1/2L BREATHING BAG (LATEX FREE), 7' O2 AND MAN
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17935688
• Report Number: 2028807-2023-00027
• Device Sequence Number: 3430251
• Product Code: BZR
• UDI-Device Identifier: 10709078011488
• UDI-Public: (01)10709078011488(10)404650
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K932709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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 Model Number: 7-N7905-I-MAN
• Device Catalogue Number: N/A
• Device Lot Number: 404650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 09/12/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/21/2023; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown