MAUDE Adverse Event Report: FLUKE BIOMEDICAL FLUKE BIOMEDICAL; IMPULSE 6000D, IMPULSE 7000DP

Model Number	IMPULSE 6000D, IMPULSE 7000DP
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction

• Brand Name: FLUKE BIOMEDICAL
• Common Device Name: IMPULSE 6000D, IMPULSE 7000DP
• Manufacturer (Section D): FLUKE BIOMEDICAL; 6920 seaway blvd; everett WA 98203
• Manufacturer (Section G): FLUKE BIOMEDICAL; 6920 seaway blvd; everett WA 98203
• Manufacturer Contact: rondii lynberg ; 6920 seaway blvd; everett, WA 98203 ; 8008504608
• MDR Report Key: 25751488
• Report Number: 0002921581-2026-00001
• Device Sequence Number: 18678773
• Product Code: DRL
• UDI-Device Identifier: 00850540007119
• UDI-Public: 00850540007119
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Relabeling,Modification/Adjustment,Notification
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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
• Operator of Device: Other
• Device Model Number: IMPULSE 6000D, IMPULSE 7000DP
• Device Catalogue Number: 2811928, 2811919
• Device Lot Number: VARIOUS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown