MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. VENTLAB; 19 MM DISPOSABLE BACTERIAL /VIRAL FILTER

Model Number BF102

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Many factors may have contributed to the bv filter become occluded such as humidity, patient size, length of procedure regardless of the cause medical intervention was needed to prevent the increase of the resistance of the bv filter which interfered with adequate ventilation.Although there was no patient harm due to the filter being replaced and the healthcare personnel were able to provide ventilation to the patient this event will be reported.Based on this information this is a reportable event.

Event Description

This case was being done in our covid or #8 with dr.(b)(6) (appendectomy).Patient o2 levels were decreasing.Anesthesia (dr.(b)(6)) had problem with maintain o2 sats.Backup anesthesia (dr.(b)(6)) came to assist.Once the bacterial filter was removed.

• Brand Name: VENTLAB
• Type of Device: 19 MM DISPOSABLE BACTERIAL /VIRAL FILTER
• Manufacturer (Section D): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED; 2710 northridge dr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544
• MDR Report Key: 11387047
• MDR Text Key: 238719019
• Report Number: 1314417-2021-00002
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/26/2021

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: No Information
• Device Model Number: BF102
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other