MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX MANUAL RESUSCITATION; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 8506P

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that the resuscitator mask was difficult to remove from the packaging.The mask was sticking to the inner bag.This was delaying therapy.No patient injury or complications were reported in relation to this event.

• Brand Name: PORTEX MANUAL RESUSCITATION
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• MDR Report Key: 11652658
• MDR Text Key: 245072504
• Report Number: 3012307300-2021-03071
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10351688431295
• UDI-Public: 10351688431295
• Combination Product (y/n): N
• PMA/PMN Number: K014115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8506P
• Device Catalogue Number: 8506P
• Device Lot Number: 200813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1