MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. SKIN SURFACE TEMPERATURE PROBE; WARMER, INFANT RADIANT

Model Number 81-010400

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary.An internal complaint (b)(4) was received indicating that a skin surface temperature probe was "reading low" during use.Samples were returned for evaluation and received (b)(6) 2018 at deroyal's campus in (b)(6).These samples are being shipped to the manufacturing facility in (b)(6) for inspection and functional testing.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

The temperature probe was reading low during use.

Manufacturer Narrative

Root cause: the root cause was determined to be a manufacturing failure.During the crimping operation, the manufacturing operator failed to establish adequate adherence between the wire and pins.Corrective action: an awareness communication was issued to manufacturing operators to avoid recurrence of the reported issue.Investigation summary an internal complaint ((b)(4)) was received indicating that a skin surface temperature probe (part 81-010400, lot 46978717) was "reading low" during use.The reporting customer confirmed the reported failure was related to just one lot number -- the lot mentioned in report 9613793-2018-00005.Additional inventory at the user facility was removed due to the reported issue, and samples from multiple lots were returned and inspected at the manufacturing facility.Of these samples, just two units from lot 47982734 were unstable.The samples tested from the lot contained in this report passed functional testing; no issues were found with this particular lot.The unstable samples from lot 47982734 were cut to determine if the instability was located in the chip or connector area.After both sides of the wire were tested, it was confirmed the problem was located in the connector side.This problem is due to a lack of adherence between the wire and pins.An inventory check of the work order in process was performed.A total of 125 units were functionally inspected and all parts were found to be within specification.The device history record for the reported lot number was reviewed for discrepancies that may have contributed to the reported issue.No issues were reported during the manufacturing process.The last two years of complaints were reviewed for similar complaints.However, only one previous complaint has been received for the same part number, and it was due to a shipping error and therefore unrelated to the reported event.Preventive action: a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The temperature probe was reading low during use.

• Brand Name: SKIN SURFACE TEMPERATURE PROBE
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park; box 180-3006, 602 parkway; la aurora, heredia 146 ; CS 146
• MDR Report Key: 8008644
• MDR Text Key: 125111985
• Report Number: 9613793-2018-00004
• Device Sequence Number: 1
• Product Code: FMT
• UDI-Device Identifier: 00749756046169
• UDI-Public: 00749756046169
• Combination Product (y/n): N
• PMA/PMN Number: K925006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-010400
• Device Lot Number: 46978717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1