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

Catalog Number 048-91

Device Problem Insufficient Heating (1287)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the serial number of the device was not provided.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "heater not heating".No patient involvement reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.It was found that the thermistor and thermal fuse were damaged, thus functional testing was unable to be performed.Because the unit was received damaged, the complaint could not be confirmed and a root cause could not be established.

Event Description

It was reported "heater not heating".No patient involvement reported.

• Brand Name: HUDSON AQUATHERM HEATER 091
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• MDR Report Key: 11065038
• MDR Text Key: 223451143
• Report Number: 3003898360-2020-01096
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 12/29/2020
• Date Manufacturer Received: 04/22/2021
• 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
• Treatment: N/A.; N/A.