MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM HEATER 091; HEATER, BREATHING SYSTEM W/WO

Catalog Number 048-91

Device Problems Power Problem (3010); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

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 returned at the time of this report.A device history record investigation did not show issues related to this complaint.A record assessment (fmea) was conducted.Revision of fmea-08-044 rev 00 was performed and the failure mode is already included, no update is required.Customer complaint cannot be confirmed based on the information received.It is necessary to receive the physical device sample to perform a proper investigation and confirm the alleged defect.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 unit shut down and will not heat up".Alleged event reported as occurring during patient use.It was reported there was no necessary medical intervention.The patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed; however, a current test could not be performed due to an open circuit.It is possible that the open circuit was due to overheating of the unit.Based on the investigation performed, the reported complaint was confirmed.All aquatherm heaters are 100% inspected during manufact uring; therefore, a defect of this type would be detected prior to release from the manufacturing facility.It was determined that operational context caused or contributed to the reported defect.

Event Description

Customer complaint alleges "the unit shut down and will not heat up".Alleged event reported as occurring during patient use.It was reported there was no necessary medical intervention.The patient condition was reported as "fine".

• Brand Name: HUDSON AQUATHERM HEATER 091
• 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: 6838743
• MDR Text Key: 84404911
• Report Number: 3003898360-2017-00962
• 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: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 048-91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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