MAUDE Adverse Event Report: SCHILLER AG ARGUS PB-1000

Model Number	3.920948
Medical Device Problem Codes	Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/17/2025 it was reported to schiller ag that the pb-1000 which was used in a host system in a cath lab seem to have malfunctionned.Upon multiple ecg resets, lead ii remained a flat line.
Event or Problem Description
On (b)(6) 2025 it was reported to schiller ag that the pb-1000 which was used in a host system in a cath lab seem to have malfunctionned.Upon multiple ecg resets, lead ii remained a flat line.

• Brand Name: ARGUS PB-1000
• Common Device Name: PB-1000
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar, zg 6341 ; SZ 6341
• Manufacturer (Section G): SCHILLER AG; altgasse 68; baar, zg 6341 ; SZ 6341
• Manufacturer Contact: stefan bigler ; altgasse 68; baar, zg 6341 ; SZ 6341
• MDR Report Key: 21384079
• Report Number: 3002808182-2025-00019
• Device Sequence Number: 8525934
• Product Code: MHX
• UDI-Device Identifier: 07613365000085
• UDI-Public: 07613365000085
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K012226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: Health Professional
• Device Model Number: 3.920948
• Device Catalogue Number: 0.760215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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