MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON THERMAGARD NEBULIZER HEATER; BREATHING SYSTEM HEATER

Catalog Number 5705

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer complaint alleges the device stopped working 3 times on a patient after just 3 days of use.There was no patient harm reported.

Event Description

Customer complaint alleges the device stopped working 3 times on a patient after just 3 days of use.There was no patient harm reported.

Manufacturer Narrative

Qn# (b)(4).The unit was returned and sent to the manufacturer (pegasus research corp) for evaluation.Pegasus reports that "upon receipt of unit the claim was confirmed.Evaluation revealed that the thermal-fuse was opened and prevented the unit from heating.The thermal-fuse was replaced and the unit operated within specifications.Dhr show that the heater was working within specifications at the time of release.The approximate age of the heater is 284 days." based on the investigation performed, the reported complaint was confirmed.The unit was repaired and returned.

• Brand Name: HUDSON THERMAGARD NEBULIZER HEATER
• Type of Device: BREATHING SYSTEM HEATER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8142195
• MDR Text Key: 129616457
• Report Number: 3011137372-2018-00321
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5705
• Device Lot Number: SN:22255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.