MAUDE Adverse Event Report: TELEFLEX HUDSON AQUATHERM HEATER 091; HEATED HUMIDIFICATION SYSTEM

Catalog Number 048-91

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

The event is reported as: the unit is not heating.The alleged defect was encountered prior to patient use.

Manufacturer Narrative

The device sample was received by the manufacturer, but the investigation is incomplete at the time fo this report.Per dhr (device history record) the product aquatherm heater 091, serial (b)(4) was manufactured on 02/20/2013.The dhr investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes were required.

• Brand Name: HUDSON AQUATHERM HEATER 091
• Type of Device: HEATED HUMIDIFICATION SYSTEM
• Manufacturer (Section D): TELEFLEX; rtp NC
• Manufacturer (Section G): TELEFLEX MEDICAL; prolongacion mision eusebio; kino # 1316,rancho el descanso; tecate, b.c. ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4094965
• MDR Text Key: 21808089
• Report Number: 3003898360-2014-00697
• Device Sequence Number: 1
• Product Code: BTT
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 048-91
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1