MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. GENERAL PURPOSE PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 81-02S409

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating that the temperature readings obtained from a general purpose probe were cycling in a "stepwise manner." a defective sample was returned june 14.The customer returned the temperature probe as well as an interface cable.The temperature probe is manufactured by deroyal.The interface cable is supplied to deroyal by (b)(4).Three functional inspections were conducted.First, the probe only was plugged into a multimeter and a result of 1352 ohms was obtained.This result is within specification.The second test was conducted with the interface cable and probe, and the results showed instability, oscillating between 1350 and 1358 ohms.During the third test, an in-process wire set that previously tested well was tested with the interface cable and an unstable result was obtained.Based on the results of this investigation, a supplier corrective action request is to be sent to (b)(4) for the defective interface cable.An inventory check was conducted on the sub-assembly wire set.A total of 125 units were checked and no rejects were reported during this inspection.The device history record for the reported lot number was reviewed.No discrepancies were identified.The sub-assembly work orders assigned to the finished good were reviewed as well, and no functional issues were reported during the manufacturing process.A two-year review of complaints was conducted, and similar complaints for inaccurate temperature readings were identified.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

The temperature reading started to cycle in a stepwise manner.

Manufacturer Narrative

Root cause: deroyal's inspection of the temperature probe and functional test results indicated the root cause to be a connection problem with the interface cable.As such, a supplier corrective action request was issued to the cable manufacturer, collins electronics.In its response, collins stated the instability may have been the result of errors during the welding process.Corrective actions: the supplier updated its work instructions during the manufacturing process to avoid recurrence of the issue.Investigation summary: an internal complaint (b)(4) was received indicating that the temperature readings obtained from a general purpose probe were cycling in a "stepwise manner." a defective sample was returned june 14.The customer returned the temperature probe as well as an interface cable.The temperature probe is manufactured by deroyal.The interface cable is supplied to deroyal by (b)(4).Three functional inspections were conducted.First, the probe only was plugged into a multimeter and a result of 1352 ohms was obtained.This result is within specification.The second test was conducted with the interface cable and probe, and the results showed instability, oscillating between 1350 and 1358 ohms.During the third test, an in-process wire set that previously tested well was tested with the interface cable and an unstable result was obtained.Based on the results of this investigation, a scar was sent to collins and a response has been received.An inventory check was conducted on the sub-assembly wire set.A total of (b)(4) units were checked and no rejects were reported during this inspection.The device history record for the reported lot number was reviewed.No discrepancies were identified.The sub-assembly work orders assigned to the finished good were reviewed as well, and no functional issues were reported during the manufacturing process.A two-year review of complaints was conducted, and similar complaints for inaccurate temperature readings were identified.Preventive action: a preventive action has not been taken at this time.The investigation is complete.If new and critical information is received, this report will be updated.

Event Description

The temperature reading started to cycle in a stepwise manner.

• Brand Name: GENERAL PURPOSE PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park, box 180-3006; 602 parkway, la aurora; heredia, heredia 146 ; CS 146
• MDR Report Key: 6677943
• MDR Text Key: 78980863
• Report Number: 9613793-2017-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• PMA/PMN Number: K925791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-02S409
• Device Lot Number: 42823136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 05/30/2017
• Supplement Dates FDA Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1