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

Qn#: (b)(4).The device involved has not been received by the manufacturer at the time of this initial report.

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 returned for evaluation.A visual exam was performed and no issues were observed.Drop testing was also performed and no issues were found.The sample had good flow.Based on the investigation performed, the reported complaint of blockage could not be confirmed.There were no issues found with the returned device.

• 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: 7822763
• MDR Text Key: 118550581
• Report Number: 8040412-2018-00222
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• 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].