MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO

Catalog Number 1770

Device Problem Restricted Flow rate (1248)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo available for review.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed due to the lack of the device sample.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time.If the device sample becomes available this investigation will be updated with the evaluation results.

Event Description

The customer alleges that the device is not putting out adequate humidity.The patients secretions are increasingly dried out compared to before.No patient harm reported.

Manufacturer Narrative

(b)(4).A sample was returned for evaluation.The lot number was originally reported as unknown; however, the sample received was from lot number 74k1500249.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The dhr shows that the product was assembled and inspected according to specifications.A visual exam was performed on the sample received and no defects were observed.Functional testing was also performed and no issues were found.The sample was found to be within specification.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

The customer alleges that the device is not putting out adequate humidity.The patients secretions are increasingly dried out compared to before.No patient harm reported.

• Brand Name: HUDSON NEBULIZER,LARGE VOLUME,VAR CONCENTRATIO
• Type of Device: NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5551982
• MDR Text Key: 42003603
• Report Number: 3004365956-2016-00187
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1770
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1