MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA NEUROSIGHT ARC ON LAPTOP; N/A

Catalog Number ST1000

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Correction mdr: initial mdr was submitted with incorrect facility regulatory number# 1222895-2015-00035.This mdr is being submitted under correct facility regulatory number.Integra has completed their internal investigation on 12/17/2015.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: after the evaluation, it was confirmed via phone call that the root cause was a use error in which liquid had been spilled onto the laptop and caused the motherboard to short out.The device history record for the unit(s) is listed in this complaint under lot code/work order (b)(4) on 12-05-2014.A total of 1 was produced of this lot.No abnormalities relate to reported incident found nor where there any variances, mrr's or reworks associated with this lot/work order number.No service history on file.A two year look back in trackwise for this reported failure and or related to "laptop is burnt " for this product id shows that no additional complaints were received.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: in summary, quality sent the defective product to the hp support center for a root cause analysis.After the evaluation, it was confirmed that the root cause was a use error in which liquid had been spilled onto the laptop and caused the motherboard to short out.

Event Description

Correction mdr: initial mdr was submitted with incorrect facility regulatory number# 1222895-2015-00035.This mdr is being submitted under correct facility regulatory number.

• Brand Name: NEUROSIGHT ARC ON LAPTOP
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5365141
• MDR Text Key: 35923270
• Report Number: 3004608878-2016-00010
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K946252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ST1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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
• Patient Age: 51 YR