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

Catalog Number 5705

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the device stopped heating during use.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the heater was received with the ring adaptor.It was found that the power switch would light up, but the unit would not generate heat.Based on the investigation performed, the reported complaint was confirmed.The unit is approximately 720 days old.The heater was found to be abused by immersion in some type of liquid, and all the inner components were damaged.It was determined that the unit was beyond economical repair.

Event Description

The customer alleges that the device stopped heating during use.The patient's condition is reported as fine.

• Brand Name: HUDSON THERMAGARD NEBULIZER HEATER
• Type of Device: BREATHING SYSTEM HEATER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6033180
• MDR Text Key: 57622586
• Report Number: 3011137372-2016-00322
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• 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 19372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1