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

Catalog Number CAM02

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Type  malfunction  

Event Description

The cable was loose on the cam02 monitor.There was no patient injury and no revision/medical intervention required.

Manufacturer Narrative

Investigation completed 05/18/2017.Method: trend analysis, failure analysis.The review encompassed dates 25-may-2016 to 25-apr-2017.There is one complaint which contained the search criteria.Since the serial number of the cam02 monitor was not provided after several documented requests, it cannot be determined if this is a single complaint occurrence for this cam02 monitor.Rate of occurrence: during the time period ¿may 2016 to apr 2017¿, the global product usage for cam02 monitors was calculated as 22,837 usages, using the total quantity of cam02 monitor catheter sales sold to calculate the quantity of usages.1 catheter is used per procedure, and is used as a means of quantifying the number of procedures undertaken.The quantity of complaints in the complaint review (1) can therefore be calculated as 0.004% (4 x 10-5) (remote) of procedures.Conclusion: product was not returned, therefore, the evaluation was unable to be performed.Therefore, an investigation for cause was unable to be performed.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6502988
• MDR Text Key: 73344124
• Report Number: 3006697299-2017-00063
• 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: health professional,user faci
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

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: CAM02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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