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

Model Number PROBE, REUSABLE GEN PURPOSE TEMP, ADULTOPEN PROBE, REUSABLE GEN PURPOSE TEMP, AD

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).The defective device/unit will not be returned for evaluation.Therefore, no root cause could be determined.However,the customer could not verify the reported issue.As a resolution, the technician replaced the ecg cable lot no.058139 and temperature probe (no batch number).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the saturometer (reusable gen purpose temperature probe) failed.At this time, the customer has not provided any information regarding patient involvement associated with the reported event.

• Brand Name: PROBE, REUSABLE GEN PURPOSE TEMP, ADULTOPEN PROBE, REUSABLE GEN PURPOSE TEMP, AD
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): MEASUREMENT SPECIALTIES INC; 1711 139th ln nw; ciudad industrial otay; andover MN 55304
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15179532
• MDR Text Key: 301558854
• Report Number: 3010838917-2022-00005
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 10190752125643
• UDI-Public: (01)10190752125643
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• 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: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROBE, REUSABLE GEN PURPOSE TEMP, ADULTOPEN PROBE, REUSABLE GEN PURPOSE TEMP, AD
• Device Catalogue Number: M1024247
• Device Lot Number: NOT PROVIDED
• 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