MAUDE Adverse Event Report: INTEGRA LIFESCIENCES IRELAND LIMITED OXYGEN PARTIAL PRESSURE (PTO2) MONITOR; PTO2 MONITORING

Catalog Number LCX02

Device Problems Break (1069); Disassembly (1168); Mechanical Problem (1384); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

The monitor has loose items inside.The sales representative wanted to show the device (demo) before transferring it to the operating room.The issue was detected by her when she removed the device from the box.There was no interaction with a patient.

Manufacturer Narrative

To date, the device involved in the reported incident has been received for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

Integra has completed their internal investigation on 08/03/2015.The investigation included: evaluation of actual device; review of device history records; review of complaints history records.Results: the dhr pack appendix 1 was reviewed for lcx02 monitor serial number (b)(4).Date of manufacture: 2013 oct¿the dhr review verified all the functionality tests were carried out accordingly and all results of the tests were recorded as within specification prior to the lcx02 monitor been released.Rate of occurrence: (b)(4).Conclusion: the customer complaint incident was confirmed and duplicated.The root cause of the complaint incident ¿loose spacer¿ is the reassembly of the lcx02 monitor during the calibration of the monitor at the service center.A manufacturing process review verified there are no assignable cause and/or anomalies associated at manufacturing process of the lcx02 monitor production process which could contribute and/or be related to the reported incident.Based on the complaint investigation and the complaint trend verification the incident is an isolated occurrence no corrective actions are deemed necessary for lcx02 monitors manufactured at (b)(4).No further actions are deemed necessary.Future incidents of this nature will be monitored and documented for recurrence and trending purposes.

• Brand Name: OXYGEN PARTIAL PRESSURE (PTO2) MONITOR
• Type of Device: PTO2 MONITORING
• Manufacturer (Section D): INTEGRA LIFESCIENCES IRELAND LIMITED; sragh, tullamore, co.; offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4865067
• MDR Text Key: 17692823
• Report Number: 3006697299-2015-00088
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K131184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: LCX02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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