MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CONNECTOR.PATIENT MONITOR MPM-; N/A

Catalog Number PMIO-MPM

Device Problems False Reading From Device Non-Compliance (1228); Product Quality Problem (1506)

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

Event Date 09/28/2016

Event Type  malfunction  

Event Description

The customer returned the pmio-mpm connector/cable along with a camino monitor serial number (b)(4) to be evaluated.The complaint was the neurosurgeon was having concerns about the readings the monitor was providing him (mfg.Report number 3006697299-2016-00179).Preliminary testing done by integra service and repair technician revealed that there was nothing wrong found with the monitor; the pmio-mpm was the one with the problem- temperature reading was not stable.

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: the reported failure was confirmed; during investigation it was observed that the returned cam02 monitor had unstable temperature reading due to failure of the returned pmiompm1 cable.The dhr review has been deemed satisfactory.Date of manufacture: oct-2015.No non-conformance issues or reports were raised during the manufacturing process for this cable.The work order (b)(4) documents the production of 100 pmiompm1 cables and was completed correctly following company work instructions.Based on complaint information, the complaint incident is trended as a failure of the camino monitor to perform its intended function due to unstable temperature reading, thus temperature display issue.A minimum of 12-month review of pmiompm1 cable customer complaints was completed in trackwise® using the following key words ¿temperature display issue¿ and ¿root cause not determined¿ in search criteria.The key word search review of the complaints contained all and/or part of the key words to complete a comprehensive trend review.This review encompassed dates 04-oct-2015 to 24-nov-2016.A total of 6 complaints were reviewed of which this is the 1st complaint that contained the search criteria.Conclusion: product was returned and the evaluation verified the complaint incident ¿temperature readings not stable¿ as valid and the customer complaint was confirmed.The root cause not determined; cause of the unstable temperature reading displayed on the customer¿s cam02 monitor was due to the faulty customer¿s pmiompm1 cable.Further incidents of this nature will be monitored for recurrence and trending purposes.

• Brand Name: CONNECTOR.PATIENT MONITOR MPM-
• 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: 6004802
• MDR Text Key: 57268750
• Report Number: 3006697299-2016-00188
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMIO-MPM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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
• Treatment: CAMINO MONITOR