MAUDE Adverse Event Report: INTEGRA LIFESCIENCES IRELAND LIMITED MONITOR 18 V DC POWER ADAPTER; ACCESSORIES-CAMINO

Catalog Number MONPWR

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the cable was being used but the adapter stopped working.There was no pt injury or delay in surgery.Additional info was requested and on (b)(6) 2014 ,the following was provided by the biomedical technician: the product problem was discovered by a nurse in the surgical intensive care unit.The biomedical technician received the camino monitor with an unsigned note saying the camino stopped working.The biomedical technician then discovered that the power adapter had no output.The date of incident was believed to have occurred around on (b)(6) 2014.It was reported that there was no pt harm.No other further info was provided.

Manufacturer Narrative

To date, the device involved in the reported incident has been received for eval.An investigation has been initiated based on the reported info.

• Brand Name: MONITOR 18 V DC POWER ADAPTER
• Type of Device: ACCESSORIES-CAMINO
• Manufacturer (Section D): INTEGRA LIFESCIENCES IRELAND LIMITED; sragh tullamore ; EI
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 3871272
• MDR Text Key: 4570314
• Report Number: 3006697299-2014-00020
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2014

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: Health Professional
• Device Catalogue Number: MONPWR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: No
• 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