MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR; ICP MONITORING

Catalog Number CAM02

Device Problems Premature Discharge of Battery (1057); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2016

Event Type  malfunction  

Event Description

A customer complained that the cam02 monitor was in need of repair due to the battery draining quickly even when the monitor was plugged in to a power source.The monitor was last serviced in (b)(6) 2016.The incident occurred on (b)(6) 2016.There was no patient harm or injury and it did not delay a procedure.

Manufacturer Narrative

Integra has completed their internal investigation on 16 may 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Evaluation of device: the cam02 monitor serial number (b)(4) was returned under rma (b)(4) to (b)(4) service centre for failure analysis evaluation.The failure analysis investigation confirmed the complaint incident.The evaluation identified the battery was draining quickly due to a faulty power board.The cam02 monitor received a replacement power board, was calibrated and safety tested as per f0421.The dhr review has been deemed satisfactory.Date of manufacture: oct 2014.No non-conformance issues or reports were raised during the manufacturing process for this device.No trend has been identified.A review of cam02 complaints was completed in the system using the key words ¿battery draining¿ in the search criteria.The review encompassed dates 31-mar-15 to 06-apr-16.A total of (b)(4) complaints were reviewed of which this complaint is the single occurrence in the search criteria.Conclusion: the customer complaint incident was confirmed.The root cause analysis identified a defective power board which caused the cam02 monitor¿s battery to drain quickly.

• Brand Name: INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5590591
• MDR Text Key: 43997756
• Report Number: 3006697299-2016-00117
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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