MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP1 110-120V EXERA II CART; WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10000285

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence is executed for this event.The power cord and the transformer of the device are the original ones provided with the device.The transformer is not available for evaluation as it has been discarded.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this issue, during preparation for use for an unknown procedure, when power was turned on the device transformer and smoke was emitted.There was no fire.No errors, alarms, alerts or warnings were received.There is no patient involvement and no harm to any anyone.The device was not inspected prior to the device being turned on.

Manufacturer Narrative

The device is not returned.As such, an actual device evaluation is not performed.An evaluation is done based on historical records and communication.This supplemental report is being submitted to provide this information.The device history record review for the device is not conducted due to age of the device.Device is 14 years old.Device was still fitted with the original power cable (as communicated by customer).This would be considered a very long life without replacement for this component.No definitive conclusion is possible on the information supplied and it has been indicated that the transformer has been disposed of by the customer and thus cannot be inspected and no further information can be obtained.Historically a problem was identified when customers change fuse on this model in that the fuse was not sufficiently tightened and this could lead to overheating and the behavior described in the complaint.This is the most probable cause.

• Brand Name: WM-NP1 110-120V EXERA II CART
• Type of Device: WM-*P1 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: 10784336
• MDR Text Key: 214521651
• Report Number: 9611174-2020-00038
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• PMA/PMN Number: CLASS1-EXMP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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
• Device Operator: No Information
• Device Model Number: K10000285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1