MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMAERICA S.R.L. DEROYAL GENERAL PURPOSE PROBE 12FR; THERMOMETER, ELECTRONIC, CLINIC

Catalog Number 81-020412

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

Root cause: no discrepancies or anomalies were identified during the investigation of the returned samples and device history record.Therefore, a root cause cannot be determined.Corrective action: because a root cause cannot be determined, no corrective actions will be taken at this time.Investigation summary: an internal complaint ((b)(4)) was received regarding a general purpose temperature probe (part number 81-020412).The customer reported that the probe was being used during a hypothermia protocol and "reads correctly on the lower number, but when the patient's temperature rises, it does not read correctly." the customer returned 25 representative samples, and a functional inspection was performed on the 25 units.The units were within resistance specification (min: 1,344 ohms; max: 1,366 ohms).Please refer to the attachment.The lot number was not provided in the initial report from the customer.However, the lot number of the returned samples was identified on the labeling as 31567229.The work order for this lot was reviewed in the device history record.No discrepancies or rejects were documented during the manufacturing process.Additionally, the functional results of the last two manufactured work orders of part number 81-020412 were reviewed.No discrepancies were identified.The corrective and preventive action (capa) and material review report (mrr) logs were reviewed for the period covering 2 years.No four mrrs have been opened due to units found out of resistance tolerance during quality inspection.Of these mrrs, one ((b)(4)) was regarding part number 74-10044, which is a sub-component within finished good (b)(4).This mrr was closed january 14, 2016, and the root cause was determined to be a failure with the multimeter used to perform the inspection.Preventive action: no preventive actions will be taken at this time.The investigation is complete.If new and critical information is received, this report will be updated.

Event Description

A general purpose temperature monitoring probe was place in the esophagus on a hypothermia protocol patient.The temperature probe would read correctly on the lower number, but when the patient's temperature rose, the probe did not read correctly.The patient was not undergoing a surgical procedure at the time but was under a hypothermia protocol.

• Brand Name: DEROYAL GENERAL PURPOSE PROBE 12FR
• Type of Device: THERMOMETER, ELECTRONIC, CLINIC
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMAERICA S.R.L.; global park, box 180-3006, 602; parkway, la aurora; heredia, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park, box 180-3006, 602; parkway, la aurora; heredia, heredia 146 ; CS 146
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5581720
• MDR Text Key: 43584156
• Report Number: 9613793-2016-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81-020412
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1