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

Catalog Number 5705

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2016

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 unit will not turn on.The reported issue was detected during use on a patient.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed on the serial number reported and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.It was received without the accessories.It was observed that the power switch does not light up, and it does not heat.The unit is approximately 3601 days of age.It was found that the unit was abused by immersion.All the inner components were damaged beyond economical repair.

Event Description

The customer alleges that the unit will not turn on.The reported issue was detected during use on a patient.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: 5604281
• MDR Text Key: 43498716
• Report Number: 3011137372-2016-00108
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• 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 9709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• 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