MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND WITH HM

Model Number DIMENSION XPAND WITH HM

Device Problem Sparking (2595)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) and reported that there was uninterrupted power supply (ups) failure on the dimension xpand with hm.The customer observed spark and loud beeping noise during the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument and determined that the uninterruptible power supply (ups) was malfunctioned.The cse replaced the blown fuse (f1) and turned on the instrument at the breaker, the breaker tripped and f1 blew.The cse removed load from the alternating current (ac) relay board, replaced f1 and turned on the instrument, f1 blew again.The cse replaced ac relay board, ac power selector board, breaker and f1.The cse bypassed ups and turned on the instrument, f1 blew again.The cse replaced transformer, fuse harness, removed direct current (dc) power supply from the circuit and powered on the instrument.The cse determined a short in the dc power supply, replaced dc power supply, powered, and primed the instrument.The cse worked with customer and replaced the integrated multisensor technology (imt) sensor and sample probe.The cse ran system check, which recovered acceptably.The cse bypassed the ups.The cause of the event is unknown.The instrument is performing according to specifications.Siemens is evaluating the event.

Event Description

The customer reported that the uninterrupted power supply (ups) of the dimension xpand with hm instrument failed and heard loud beeping noise.The customer stated that they observed sparks but there were no visible flames or smoke associated with the event.There are no known reports of adverse health consequences nor delay in reporting results due to the event.

Manufacturer Narrative

Siemens filed the initial mdr 2517506-2023-00263 on 30-nov-2023.Additional information (05-jan-2024): in addition to the service actions mentioned in the initial report, the siemens customer service engineer (cse) ran quality control (qc) after completing all the troubleshooting activities, which recovered acceptably.Siemens evaluated the event and determined that the replacement of the direct current power supply and bypassing the instrument's external uninterruptible power supply, as detailed in the initial report, resolved the issue.This is an isolated event.The instrument is performing according to specifications.No further evaluation of these devices is required.

• Brand Name: DIMENSION XPAND WITH HM
• Type of Device: DIMENSION XPAND WITH HM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18237875
• MDR Text Key: 329375807
• Report Number: 2517506-2023-00263
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION XPAND WITH HM
• Device Catalogue Number: 10444836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• 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