MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON THERMAGARD NEBULIZER HEATER

Catalog Number 5705

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges the on/off switch is not working.The device will not power on.Alleged issue reported as occurring during use.Customer reports no harm to patient.

Manufacturer Narrative

(b)(4).The sample was returned and sent on the manufacturer (b)(4).Pegasus reports that upon receipt of the unit it was found that the heater was abused by impact and a severe crack was present in the main housing at the front panel.It was also found that the power switch rocker has a bump and is not lighting up, and the unit was not heating.The approximate age of the heater is 3164 days of age.Based on the investigation performed, the complaint was confirmed.The unit will be repaired and returned.

Event Description

Customer complaint alleges the on/off switch is not working.The device will not power on.Alleged issue reported as occurring during use.Customer reports no harm to patient.

• Brand Name: HUDSON THERMAGARD NEBULIZER 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: 7545521
• MDR Text Key: 109456081
• Report Number: 3011137372-2018-00149
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• 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:9726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2018
• 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: Reuse
• Patient Sequence Number: 1