MAUDE Adverse Event Report: HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO

Model Number IPN913687

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "customer states the cuff adaptor on the expiratory limb appears to be a loose connection to their ventilator expiration port".No patient involvement reported.

Manufacturer Narrative

Qn# (b)(4).One (1) 2415 corrugated comfort flo was received for investigation.A concha smart column and pressure relief valve were also returned.No defects or anomalies were observed.R & d was consulted as part of this investigation.The expiratory limb of the returned circuit was connected to an i-servo and a drager lab inventory ventilator.The expiratory limb to ventilator port connection appeared snug on both ventilators.Circuit could only be disconnected after a pulling force was applied.Manufacturing was consulted.Per manufacturing, sample was visually inspected and no defects or anomalies were observed.Sample was compared to production samples and there were no observed differences.A device history record review was performed and no relevant findings were identified.The complaint could not be confirmed.In an attempt to replicate the reported defect, the returned sample was connected to a concha neptune and concha water bottle.The air flow was set at 60lpm to account for the worst case scenario.When the circuit was kinked , the pressure relief valve released any excessive pressure and functioned as expected.The pressure relief valve was disconnected and re-connected to the other port on the column with the same results.No evidence of water squirting or exiting the column was observed.The situation could not be recreated even at the highest flow settings.The pressure relieve valve met all the design requirements.Per r & d, it's possible that there was excessive rainout in the reservoir drain which could have squirted out as the patient turned over, if the reservoir wasn't emptied prior.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported "customer states the cuff adaptor on the expiratory limb appears to be a loose connection to their ventilator expiration port".No patient involvement reported.

• Brand Name: HUDSON VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• MDR Report Key: 11761071
• MDR Text Key: 248587520
• Report Number: 3004365956-2021-00175
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 14026704658920
• UDI-Public: 14026704658920
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN913687
• Device Catalogue Number: 1613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/07/2021
• 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
• Treatment: VENTILATOR; VENTILATOR; VENTILATOR.