MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; LAVAGE, JET

Model Number 66800039

Device Problems Circuit Failure (1089); Electrical Power Problem (2925)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/06/2017

Event Type  malfunction  

Event Description

It was reported blown fuse found in unit.Replaced the fuse but as soon as the unit is plugged in the fuses would blow.Customer replaced the fuses twice and getting the same issue.

Manufacturer Narrative

Please see investigation summary.(b)(4).

• Brand Name: VERSAJET II CONSOLE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU32B N; UK HU32BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 76. s meridan avenue; oklahoma city OK 73107
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6731537
• MDR Text Key: 80882149
• Report Number: 8043484-2017-00178
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• 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: 10/04/2017

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?: No
• Device Operator: No Information
• Device Model Number: 66800039
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 10/04/2017
• 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: Unknown
• Patient Sequence Number: 1