MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM III,ELECTRONIC HEATER; HEATER, BREATHING SYSTEM W/WO

Catalog Number 050-14

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

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not received by the manufacturer at the time of this report.A device history record review could not be conducted since the serial number provided is not a valid number.A record assessment (fmea-08-043 rev.02) was performed and no update required.It is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect reported.Customer complaint cannot be confirmed based on the information received.Corrective actions cannot be established at this time.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges the heater is no longer heating.There was no report of patient involvement.There was no report of patient harm.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and it was discovered that the unit did not heat.The sample was opened and it was observed that the components (pcb board and potentiometer) were damaged.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the issue could not be established.It was not known why the components were damaged.All aquatherm heaters are 100% tested by manufacturing; therefore, it is unlikely that the issue found in the sample occurred during manufacturing.This defect would have been detected during the final inspection test.It is possible that the damage on the unit was due to mishandling, although this could not be confirmed.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not determined.

Event Description

Customer complaint alleges the heater is no longer heating.There was no report of patient involvement.There was no report of patient harm.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6771346
• MDR Text Key: 81956420
• Report Number: 3003898360-2017-00873
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 050-14
• Device Lot Number: SN:612010083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• 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