MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; BYPASS HME

Model Number DYNJAABHME

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

The particles within the filter could potentially be inhaled by patient.

Event Description

Blue "particle flakes "were observed in the inside housing/hme area. .

Manufacturer Narrative

The particles within the filter could potentially be inhaled by patient.The complaint of "blue "particle flakes "were observed in the inside housing/hme area" regarding part dynjaabhme was confirmed.The root cause was not determined but could possibly be due to the design of the component structure.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.Complaints will continue to be monitored for possible trends.

Event Description

Blue "particle flakes "were observed in the inside housing/hme area. .

• Brand Name: SUNMED LLC
• Type of Device: BYPASS HME
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18804829
• MDR Text Key: 337630602
• Report Number: 1314417-2024-00014
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJAABHME
• Device Catalogue Number: DYNJAABHME
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other