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

Catalog Number MONPWR

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

Event Description

It was reported that a monpwr monitor 18 v dc power adaptor fell apart.There was no patient involvement with this event.

• Brand Name: MONITOR 18 V DC POWER ADAPTER
• Type of Device: ACCESORIES-CAMINO
• Manufacturer (Section D): INTEGRA LIFESCIENCES IRELAND LIMITED; sragh tullamore co. offlay ; EI
• Manufacturer Contact: linda serrentino ; 315 enterprise dr.; plainsboro, NJ ; 6099365560
• MDR Report Key: 3959801
• MDR Text Key: 21167519
• Report Number: 3006697299-2014-00061
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• 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
• Date Manufacturer Received: 06/06/2014
• 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