MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD. MULTI-PARAMETER MONITOR, DOSMETIC, W WAVEFORM, I

Catalog Number MPM16

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Data Problem (3196)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2015

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

The device was being used for monitoring trepanation and intracranial pressure (icp).After two days of monitoring, it was noticed that monitor was not recording the (icp) curve nor temperature, showing a picture of error in the display.The user proceeded to the revision of the couplings but the problem persisted.The monitor was changed and it recorded the icp and temperature normally.There was no patient injury and no surgery delay.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.The reported failure was verified and duplicated.Customer complaint was confirmed.Dhr review was completed for mpm1 monitor serial number (b)(4), to identify any recorded anomalies that could be associated to the complaint incident.Date of manufacture: (b)(6) 2012.All results of the functionality tests were recorded as within specifications prior monitor been released.A minimum of 12 month review of mpm1 monitor customer complaints was completed in trackwise® using the following key words ¿display issue¿ and a root cause ¿analog pcb¿ in the search criteria.The analysis of the complaint investigations and root cause reports has concluded this is the 1st identified complaint for the reported failure associated with the mpm1 monitor due to faulty analog board.No trend has been identified.No review of non-conformance reports is deemed necessary as no trend has been identified.No further actions are deemed necessary.Future complaints will be continued to be monitored and trended.The failure analysis investigation has concluded the root cause of the mpm1 monitor not recording icp curve or temperature was due to faulty analog board.

• Brand Name: MULTI-PARAMETER MONITOR, DOSMETIC, W WAVEFORM, I
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire SP104 DR; UK SP104DR
• Manufacturer (Section G): INTEGRA NEUROSCIENCES, LTD; newbury road; andover hampshire ; UK
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4918162
• MDR Text Key: 22400080
• Report Number: 8010219-2015-00032
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MPM16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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: 63 YR