MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) SINGLE PARAM ICP MONITOR; N/A

Catalog Number SPM-1

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

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

Event Date 12/13/2015

Event Type  malfunction  

Event Description

It was reported that there was a problem with values on the device.It was unknown if the device was in contact with a patient, if a patient was injured, or if the event led to an increase in surgery time.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 05feb2016.The investigation included: methods: evaluation of actual device.Review of service history records.Review of complaint history.Results: evaluation of device: during investigation it was observed that the pre amp connector was twisted which is consistent with an improper use of the device by the user.Twisting of the connector resulted in damaging the spm1 monitor¿s internal flex cable.This failure of the broken internal flex cable can be concluded due to physical damage.The reviewed service history documentation for spm1 monitor serial number (b)(4) has identified no impact on complaint incident.The dhr review has been deemed satisfactory.A minimum of 12 month review of smp1 monitor customer complaints was completed using the key words ¿display issue¿ and a root cause ¿physical damage¿ win the search criteria.This review encompassed from dates 04-jan-2015 to 01-feb-2016.(b)(4).The failure analysis investigation has concluded the root cause of the spm1 monitor¿s problem with values was due to broken spm1 monitor¿s internal flex cable, resulted from twisted pre amp connector.This failure is consistent with an improper use of the device by the user, concluded due to physical damage.

• Brand Name: SINGLE PARAM ICP MONITOR
• Type of Device: N/A
• 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: 5392729
• MDR Text Key: 37340338
• Report Number: 3006697299-2016-00076
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K031086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SPM-1
• Device Lot Number: 2072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2002
• 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