MAUDE Adverse Event Report: GYRUS ACMI, INC. ES4K-3500 LARGE OR, 35 RU, REMOTE RACK; DIGITAL IMAGE STORAGE

Model Number ISM-1007375

Device Problem Break (1069)

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

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) visited the customer site.The reported issue was confirmed.It was observed that both monitors had sustained damage around the front display.The issue was resolved by replacing the monitors.Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported that the monitors have damage to the front display.There was no report of patient or user injury due to the event.

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction.Additional information was received from the customer stating the monitors were operational and the cracked monitor was not in use with a patient in the room so there was no patient involvement.No device malfunction occurred.

• Brand Name: ES4K-3500 LARGE OR, 35 RU, REMOTE RACK
• Type of Device: DIGITAL IMAGE STORAGE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17830086
• MDR Text Key: 324457079
• Report Number: 3011050570-2023-00146
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ISM-1007375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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