MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 1ST RESPONSE ADULT MANUAL RESUSCITATORS; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 8503

Device Problem Device Alarm System (1012)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.Dhr: awaiting product return to smiths medical for lot confirmation.

Event Description

It was reported that a pt.Was leaving the operating room it was found that 02 was not flowing through the ambu bag to the patient.Crna asked for a new ambu bag and the anesthesiologist got a new one.Patient transported.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

Additional information received via email stating that the issue was resolved.

• Brand Name: PORTEX 1ST RESPONSE ADULT MANUAL RESUSCITATORS
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13515588
• MDR Text Key: 285479606
• Report Number: 3012307300-2022-03232
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10351688431257
• UDI-Public: 10351688431257
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8503
• Device Catalogue Number: 8503
• Device Lot Number: 191212
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 120 KG