MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD MULTI-PARAMETER MONITOR, DOMESTIC, W WAVEFORM, I; N/A

Catalog Number MPM1

Device Problems No Device Output (1435); Loss of Power (1475); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

During use for the patient (age and gender unknown), the unit suddenly shut down.At that time, the unit had been used with the ac adapter.There was no patient injury.The event did not lead to an increase in surgery time.The incident occurred after surgery; during follow up to the intensive care unit (icu).Patient outcome was reported as "no change." the distributor sales staff visited the hospital and checked the unit and the following were observed: the unit suddenly emitted a beep sound and the battery indication lit up red after 10 minutes of normal operation.Right after the alarm, the unit shut down.Additional information has been requested.

Manufacturer Narrative

Additional information received on 15dec2015: date of the incident was on (b)(6) 2015.The monitor shut down with ac source.Type of surgery performed was unknown.No trouble shooting measures were performed on the device.Replacement unit was used.There was no treatment/monitoring delay.Integra has completed their internal investigation on (b)(4) 2015.The investigation included: methods: -evaluation of actual device -review of device history records.-review of complaint history.Results: evaluation of device: the monitor display had no function due to a faulty digital and analog board.Also, the battery was expired since jan2006 and the battery did not hold any charge.As part of the repair, the digital pcb, analog pcb, the battery and the monitor¿s sticky feet will be replaced.The mpm1 monitor will be calibrated and tested to specifications prior to return to the customer.Dhr review was completed for mpm1 monitor serial number mma040101, work order 510459, to identify any recorded anomalies that could be associated to the complaint incident.Date of manufacture: jan-2004.No non-conformance report was raised during manufacturing process for this monitor.No service history for mpm1 monitor serial number mma040101.The dhr review has been deemed satisfactory.The analysis of the complaint investigations and root cause reports has concluded the complaint is the 2nd identified complaint for the reported failure associated with the mpm1 monitor due to a faulty digital board and 1st complaint due to a faulty analog board.No trend has been identified.The customer complaint incident ¿during use for the patient, the display suddenly shut down¿ was verified and duplicated.The root cause of the complaint incident was due to a faulty digital and analog pcb which resulted in the mpm1 monitor to shut down during use with no icp (intracranial pressure) information displayed.

• Brand Name: MULTI-PARAMETER MONITOR, DOMESTIC, W WAVEFORM, I
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD; newbury road; newbury road; andover hampshire ; UK
• 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: 5286291
• MDR Text Key: 33848938
• Report Number: 8010219-2015-00068
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

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: MPM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2004
• 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