MAUDE Adverse Event Report: HUDSON CONCHAPAK SW 1650 ML W/COLUMN; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 385-60

Device Problem Material Separation (1562)

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

Event Date 12/06/2020

Event Type  malfunction  

Manufacturer Narrative

Qn #: (b)(4).

Event Description

It was reported, "the patient was on a drager in aprv mode.The therapist heard a sound, and found that they column was leaking and the top had separated from the column." no reports of medical intervention required.Patient reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 385-60 column for investigation.Upon receipt the column was visually inspected for outward, visible signs of misuse/abuse/neglect.The plastic cap of the column was completely separated from the column body.It was determined that the likely root cause for the damaged observed on the column was undue force.The cracks in the top cap indicate that it encountered some trauma.It is likely that the column got stuck in a heater and was forcefully removed causing the cap to separate.The medication on the exterior of the column also suggests that medication leaked down into the column, further suggesting misuse of the device.The complaint has been confirmed.The investigation revealed a damaged column.The root cause for the failure is user error.The plastic of the column can become cracked when encountering undue force.Undue force can occur if the device is hit against a rigid surface.

Event Description

It was reported "the patient was on a drager in aprv mode.The therapist heard a sound and found that they column was leaking and the top had separated from the column".No reports of medical intervention required.Patient reported as fine.

• Brand Name: HUDSON CONCHAPAK SW 1650 ML W/COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11057772
• MDR Text Key: 223470711
• Report Number: 1417411-2020-00045
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K760866
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 385-60
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/26/2021
• 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