MAUDE Adverse Event Report: HAMILTON MEDICAL AG HAMILTON MEDICAL AG; HAMILTON-MR1

Model Number HAMILTON-MR1

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

Hamilton medical ag case number is: (b)(4).

Event Description

The following was reported to hamiton medical ag: during set up, sent in for teslaspy red x and alarming.Would not reset.No patient involvement.

• Brand Name: HAMILTON MEDICAL AG
• Type of Device: HAMILTON-MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: christof mueller ; via crusch 8; bonaduz, 7402 ; SZ 7402
• MDR Report Key: 19077391
• MDR Text Key: 339783437
• Report Number: 3001421318-2024-00874
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07630002800761
• UDI-Public: 07630002800761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAMILTON-MR1
• Device Catalogue Number: 161010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• 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