MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA COLUMN SHELFPAK,PED PAR; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 382-30

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

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 or a picture of the alleged defect was not provided at the time of this report.A device history record review could not be conducted since the lot number was not provided.No conclusion can be established at this time based on the lack of device sample.It is necessary to have the device sample in order to perform a thorough investigation.Customer complaint cannot be confirmed.Root cause cannot be determined.No corrective actions can be assigned at this time.If the device sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the "column top separated from column canister when therapist tried to remove from neptune heater".Alleged issue reported as occurred during use.It was reported there was no patient injury or consequence.It was reported the canister was not saved, but the top and circuit are available to return.

Manufacturer Narrative

(b)(4).The top side (gas portals) of a 382-30 low-compliance concha column and an unidentified infant breathing circuit were returned for evaluation.The complaint sample represents only a part of the whole low-compliance column and cannot be tested.The top plastic portal cap of the column has separated from the body of the column.The root cause of the damaged condition has been assigned to "damaged during use".Looking at the white piece of sealing tape used to bond the aluminum column to the plastic portal cap, the tape is torn with ragged edges indicating the top piece did not simply separate.There had to be a twisting/turning force to cause such a pattern on the tape.It is not known what might have caused the column to "jam" in the neptune, but significant force was applied to the plastic portal cap to create the ripping/tearing affect.The complaint has been confirmed.

Event Description

Customer complaint alleges the "column top separated from column canister when therapist tried to remove from neptune heater".Alleged issue reported as occurred during use.It was reported there was no patient injury or consequence.It was reported the canister was not saved, but the top and circuit are available to return.

• Brand Name: HUDSON CONCHA COLUMN SHELFPAK,PED PAR
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7625964
• MDR Text Key: 111903626
• Report Number: 1417411-2018-00044
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K820878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEPTUNE HEATER; NEPTUNE HEATER; NEPTUNE HEATER