MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. DISP RESPIRATORY COMPONENT MODULE ASSY B100 FRENCH; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Catalog Number 510A1960NF

Device Problem Key or Button Unresponsive/not Working (4063)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d5.Operator of device is unknown; no information has been provided to date.Investigation summary: the customer reported that the time of expiratory knob was out of order with the max and min position damaged.One respiratory component module was received for evaluation.Visual inspection was performed, and the device was found to be in good physical condition.Functional testing was also performed, with the t exp button unable to set the value.The root cause was found to be the loosened knob holder.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.As a result of the investigation, the holder and knob will be replaced and adjusted, and must pass all functional tests before being shipped back to the customer.

Event Description

It was reported that the t exp button was out of order.There was no patient involvement and no harm/adverse event reported.

• Brand Name: DISP RESPIRATORY COMPONENT MODULE ASSY B100 FRENCH
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; enterprise way; luton LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18596149
• MDR Text Key: 334654215
• Report Number: 9611178-2024-00031
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2024

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: Other
• Device Catalogue Number: 510A1960NF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1