MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-GARD HEPA LIGHT,CLEAN; FILTER, BACTERIAL, BREATHING-C

Catalog Number 28022

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "filter in use on expiratory side of vent (servo-i) using 880-36kit circuit.Filter works fine for a few hours and then restricts flow setting off vent alarm.(cont.) clinician said it acts like a one way valve is closing inside filter." it was reported there was no patient injury or consequence.Patient condition reported as "fine".

Event Description

Customer complaint alleges "filter in use on expiratory side of vent (servo-i) using 880-36kit circuit.Filter works fine for a few hours and then restricts flow setting off vent alarm.Clinician said it acts like a one way valve is closing inside filter." it was reported there was no patient injury or consequence.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; therefore, ten pieces of the same product code were selected from current production at the manufacturing facility.The samples were visually inspected and no defects were observed.They were also drop tested and no issues were encountered.All ten samples passed the drop test.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HUDSON ISO-GARD HEPA LIGHT,CLEAN
• Type of Device: FILTER, BACTERIAL, BREATHING-C
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 7822789
• MDR Text Key: 118547936
• Report Number: 8040412-2018-00225
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• PMA/PMN Number: K954828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 28022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERVO 1 VENTILATOR, 880-36KIT CIRCUIT[HUDSON].; SERVO 1 VENTILATOR, 880-36KIT CIRCUIT[HUDSON].