MAUDE Adverse Event Report: HAMILTON MEDICAL AG INTELLICUFF; INTELLICUFF PRESSURE CONTROLLER

Catalog Number 951001

Device Problem Gas/Air Leak (2946)

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

Event Date 05/22/2023

Event Type  malfunction  

Manufacturer Narrative

Hamilton medical ag case number is cer (b)(4).Investigation is ongoing.

Event Description

The following was reported to hamilton medical ag: this event was reported to hamilton as a crack was noticed at the cuff pressure tube connector.The hospital staff claimed that the intellicuff pressure controller was never dropped, nor was unnecessary force applied to the cuff pressure tube connector.This occurrence was noticed during a visual inspection of similar equipment in the hospital what show the same defect.The device log files, and a video were provided to hamilton.There is no patient involvement reported.There is no need for any medical intervention reported.Neither delay in treatment nor harm to the patient, user or third party has been reported.The investigation is still ongoing.

• Brand Name: INTELLICUFF
• Type of Device: INTELLICUFF PRESSURE CONTROLLER
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crush 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crush 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 18253482
• MDR Text Key: 329574237
• Report Number: 3001421318-2023-04056
• Device Sequence Number: 1
• Product Code: BSK
• UDI-Device Identifier: 07630002800839
• UDI-Public: 07630002800839
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 951001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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