MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-DP2 WORKSTATION SET 1 - UK; WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10020641

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problems Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Reported in an abundance of caution.Field service engineer (fse) attended site on 9 december 2020.Waiting for report following site visit to be submitted.Outcome of fse report will determine next steps.

Event Description

Customer reported that users could smell faint burning smell and overheating.This occurred and was noticed during procedures.No harm to patient or user.Procedures carried out as normal and no delays.Users did re-locate to another room as a precaution.

Manufacturer Narrative

Reference the technical report provided.The device was inspected by a field service engineer.There was no evidence of burning.It was cleaned of dust and left to run for an hour - no smell or fault found.Equipment returned to use.H3 other text: field service engineer attended site.

• Brand Name: WM-DP2 WORKSTATION SET 1 - UK
• Type of Device: WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex SS2 5 QH; UK SS2 5QH
• MDR Report Key: 11028741
• MDR Text Key: 222665336
• Report Number: 9611174-2020-00040
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10020641
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1