MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-1000 AUTOMATED ANALYZER SYSTEM

Catalog Number	001100
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the instrument was not powered on and there was a burning plasic/electrical smell coming from near the instrument.No smoke or sounds was noticed by the customer.The customer was notified by the technical service team to not attempt to use the instrument and unplug the power cable from the wall outlet.A field service engineer was sent to the customer's site.Upon arrival, the field service engineer confirmed with the customer that the issue occurred after an electrical issue at the customer site.This caused a large amount of electricity to flow into the instrument's ups, or backup battery, which caused it to overcharge and fail.The field engineer replaced the ups and confirmed no damage to cable setup of the instrument.There was no damage or risk of fire from the instrument itself.The instrument is operating within specifications.
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.

• Brand Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Common Device Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 19161629
• Report Number: 9610824-2024-00011
• Device Sequence Number: 15286400
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: BK170019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/23/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown