MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) MULTI-PARAMETER MONITOR, DOMESTIC, W WAVEFORM, I; N/A

Catalog Number MPM1

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the device was damaged.It was not used in any kind of surgery and there was no patient involvement.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 11/25/2016.The investigation included: methods: -evaluation of actual device.-review of device history records.-review of complaint history.Results: evaluation of device: reported failure was confirmed; during investigation it was observed that the mpm1 monitor could not pass the logo screen resulting in no icp and no ict readings displayed due to a faulty icp flex cable and a faulty ict cable.As part of the repair, the faulty icp flex cable and ict cable were replaced and the monitor was calibrated and tested to specifications prior been returned to customer.The dhr review has been deemed satisfactory.Date of manufacture: apr-2007.The dhr review was completed for mpm-1 monitor serial number (b)(4); work order (b)(4) manufactured in (b)(4) to identify any recorded anomalies that could be associated to the complaint incident.Note: reported (b)(4) is not a valid monitor serial number.The work order (b)(4) documents the production of serial number (b)(4), split batch 4 of 15 and was completed correctly following company work instructions.Based on the complaint description, it can be concluded that the complaint incident is a failure of the mpm-1 monitor to perform its intended function with no specified failure, thus device not working.A minimum of 12 months¿ review of mpm-1 monitor complaints was completed in trackwise® using the following key words ¿device not working¿ and a root cause ¿icp flex cable & ict cable faulty¿ in the search criteria.The key word search review contained all and/or part of the key words to complete a comprehensive trend review.This review encompassed dates 17-aug-2015 to 21-nov-2016.A total of 5 complaints were reviewed of which 4 complaints contained the search criteria.Conclusion: product was returned and the evaluation verified the complaint incident ¿monitor damaged¿ as valid.Customer complaint was confirmed.Root cause determined; cause of the mpm1 monitor not working was due to a faulty icp flex cable and a faulty ict cable resulting in no logo screen and no icp and no ict readings displayed.No corrective / preventative action is deemed necessary as no trend has been identified.Further incidents of this nature will be monitored for recurrence and trending purposes.

• Brand Name: MULTI-PARAMETER MONITOR, DOMESTIC, W WAVEFORM, I
• 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: 5917139
• MDR Text Key: 54335052
• Report Number: 3006697299-2016-00177
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• 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: 11/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• 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