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

Catalog Number MPM16

Device Problems Failure to Power Up (1476); Failure to Transmit Record (1521); Out-Of-Box Failure (2311); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/30/2015

Event Type  malfunction  

Event Description

This is the first of two reports.This is in regards to the mpm 16 (multiparameter monitor).Everything worked fine during the surgery but five days after the surgery, the user proceeded to check the monitors pic connected and found out that there were some flaws in the display and didn't show integra's initiation image.The monitor was revised and tried the cables with a different monitor but still the screen didn't start.The cable charges normally and the black wire pac-1 didn't record temperature.There was patient involvement.There was no patient injury or death alleged.No product revision other medical intervention was needed.This was not an out of box failure.Additional information was received on 05may2015 with the following: the mpm16 and pac1 cable were used together on the (b)(6) patient.It worked fine and had no problems for the 5 days it was used to monitor the patient.There was no patient injury.On the next day (sixth day), the specialist decided to withdraw the monitoring and after checking and verifying the monitor, it was found that it didn't turn on.The head nurse removed the sensor and turned off the monitor as usual.After patient use, the mpm16 and pac1 cable were checked by the distributor and the 2 problems were found: the mpm didn't show integra initiation image and pac1 cable did not record temperature.When the mpm16 monitor didn't turn on, the distributor needed to verify the correct operation of the pac1 cable so it was connected to a different monitor, simulating a monitoring session, using a sensor sample that the distributor had on site.To simulate monitoring with the sample sensor, the pac1 cable records the pic but doesn't record the temperature, reason why the distributor verified it was also a cable damage.

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.

Manufacturer Narrative

Integra completed its internal investigation 07/15/2015.Method: dhr review, review of complaint management database for similar complaints, visual.Results: a dhr review was completed for mpm1 monitor serial number (b)(4).Date of manufacture january 2011.The dhr documentation was reviewed to identify any recorded anomalies that could be associated to the complaint incident.All results of the functionality tests for mpm1 monitor serial number (b)(4) (appendix 4) were recorded as within specifications prior monitor been released.A review of camo2 complaints was completed using the following key words "sensor board" in the search criteria.The review encompassed dates january 16, 2014 to january 30, 2015.The analysis identified 16 complaints for sensor board incidents.The quantity of complaints over the 12 month period with the key words identified in the complaint review can therefore be calculated as 0 2% of procedures.Reported failure was not confirmed, no fault was found with the monitor the mpm16 monitor passed all incoming tests with test cables.The pac1 cable serial number (b)(4) returned by the customer was faulty, cable had no ict output and the icp signal was unstable on display, (b)(4) has been opened for the cable.As part of the service, the monitor battery and battery door were replaced.The monitor was calibrated and tested to specifications prior to being returned to customer.Conclusion: the complaint incident could not be duplicated and the mpm1 monitor was verified as working to specifications.Therefore, no root cause can be established.

• Brand Name: MULTI-PARAMETER MONITOR, DOMESTIC, W WAVEFORM, I
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire SP104 DR; UK SP104DR
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4759529
• MDR Text Key: 18028163
• Report Number: 8010219-2015-00025
• 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: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MPM16
• Device Lot Number: MMMC1000202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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