MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC DISPOSABLE CIRCUITS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number 100/905/340-CH

Device Problem Leak/Splash (1354)

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

Event Date 04/01/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, the customer noticed the relief pressure value did not go up to the assigned one.It was suspected there was leakage from the air circuit.No patient injury was reported.

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).One sample was received for investigation.Visual inspection confirmed that in the middle of the circuit, it confirmed that there was a scratch on it about 50 cm from the tip of the connector on the device side.No other analysis was performed.The root cause was unable to be determined.A corrective and preventative action was opened by the supplier to address the reported issue.

• Brand Name: PNEUPAC DISPOSABLE CIRCUITS
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16861931
• MDR Text Key: 314479386
• Report Number: 3012307300-2023-04983
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 15019517160215
• UDI-Public: 15019517160215
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2023
• Device Model Number: 100/905/340-CH
• Device Catalogue Number: 100/905/340-CH
• Device Lot Number: 200518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1