MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH KIT, VYNTUS WALK; Oximeter

Catalog Number	28899-001
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection of the unit under test (uut) found the screen bulging at the center and separating from the tablet.The functional check revealed that the uut was attempted to be turned on but would not boot up.It was connected to a charger for 45 minutes and would not charge or boot up.It is determined that the battery is faulty and has swelled internally causing the screen to separate and is preventing the tablet from booting up and functioning.Therefore, the complaint could be confirmed and the root cause can be attributed to the swelling faulty battery.The broken tablet was replaced.The risk evaluation results in a risk acceptance level of a medium acceptable health risk.
Event or Problem Description
Initially it was reported by the customer that the tablet does not work.The screens are separating and it does not power up.The device was returned for an investigation.On 29-may-2024 it was found, that the battery of the device is swollen.The awareness date will be changed to the 29-may-2024, because the initial description of the failure did not indicate a reportable event.There was no patient involvement reported.

• Brand Name: KIT, VYNTUS WALK
• Common Device Name: Oximeter
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204 ; 2402760001
• MDR Report Key: 19557722
• Report Number: 9615102-2024-00148
• Device Sequence Number: 4734913
• Product Code: DQA
• UDI-Device Identifier: 54250892904899
• UDI-Public: (01)54250892904899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 28899-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown