MAUDE Adverse Event Report: GMS-GESELLSCHAFT FUR MEDIZINISHE PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP.; LICOX BOLTS CATHETERS & KITS

Catalog Number CC1P1

Device Problem Improper Device Output (2953)

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

Event Date 02/09/2016

Event Type  malfunction  

Event Description

The customer stated they were getting unlikely readouts on the licox bolt (e.G.A brain temperature of a degree or two cooler than body temperature).In addition, the analogue voltage output taken from the back of the licox bolt that they use to input into the software was also giving rather unbelievable values but completely different values to that seen on the front panel display.There was no patient injury or death alleged.The event did not lead to an increase of surgery time.Additional information has been requested.Linked to mfg.Report number: 9617494-2016-00002.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2016.The device was not returned for evaluation.No anomalies have been reported.No ncr or any variances were associated with this lot.The lot met the specification at the time of release.No further complaints with the same failure mode were found; no trend.The root cause could not be established since the product was not returned.

Manufacturer Narrative

Integra has completed their internal investigation on 03may2016.The product was returned for evaluation.The cc1.P1 was returned without protective sleeve.The optical inspection didn¿t show any abnormalities.The cc1p1 was evaluated by conducting an oxygen measurement performance test in water at 37°c bath temperature with an oxygenation of 20.9%, 6.01% and 0%.Furthermore, a temperature performance test was conducted at two temperatures.The cc1.P1 measured 36.81°c at a reference temperature of 36.85°c and 22.00°c at a reference temperature of 21.98°c.The performance test results for oxygen and temperature measurement were within specification.Furthermore, 2 additional cc1.P1 (boxed as new) from the same batch were sent back for investigation.Both were evaluated by conducting an oxygen measurement performance test in water at 37°c bath temperature with an oxygenation of 20.9%, 6.01% and 0% and a temperature performance test by applying two temperatures.The performance test results for oxygen and temperature measurement were within specification.In summary, the ref cc1p1 didn¿t show any damages.The oxygen and temperature measurement performance test passed for the complained catheter as well as for the two additional returned, boxed as new catheters.The reported problem with an underestimating of the temperature signal couldn¿t be reproduced.The catheters measured temperature within specification.The involved licox monitoring devices were sent to the service center.The analogue output testing was within specification.So the malfunction must be searched in the third party devices which were used by the hospital.

• Brand Name: PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP.
• Type of Device: LICOX BOLTS CATHETERS & KITS
• Manufacturer (Section D): GMS-GESELLSCHAFT FUR MEDIZINISHE; sodentechnik-gms mbh; sodentechnik-gms mbh; keil-mielkendorf 24247
• Manufacturer (Section G): GMS-GESELLSCHAFT FUR MEDIZINISHE; sodentechnik-gms mbh; dorfstrabe 2a; keil-mielkendorf 24247
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5479754
• MDR Text Key: 40027032
• Report Number: 9617494-2016-00004
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K040235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CC1P1
• Device Lot Number: 230415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1