MAUDE Adverse Event Report: VYAIRE MEDICAL OY PROBE, REUSABLE GEN PURPOSE TEMP, ADULT; THERMOMETER, ELECTRONIC, CLINICAL

Model Number PROBE, REUSABLE GEN PURPOSE TEMP, ADULT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2022

Event Type  Injury  

Event Description

It was reported to vyaire medical that the ecg cable was malfunctioning.There was patient involvement and the patient was transferred to another station without any impact.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.This report is for the temperature cable.Please see (b)(4) for the probe, reusable gen purpose temp, adult.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: PROBE, REUSABLE GEN PURPOSE TEMP, ADULT
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 95137 ; FI 95137
• Manufacturer (Section G): MEASUREMENT SPECIALTIES INC; 1711 139th ln nw; andover MN 55304
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15169972
• MDR Text Key: 297312240
• Report Number: 3010838917-2022-00003
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 10190752125643
• UDI-Public: (01)10190752125643(10)095137
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROBE, REUSABLE GEN PURPOSE TEMP, ADULT
• Device Catalogue Number: M1024247
• Device Lot Number: 95137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention