MAUDE Adverse Event Report: APK TECHNOLOGY CO., LTD. PULSE OXIMETER SENSOR

Model Number NK-SPO2-ADVT

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

Describe event : spo2 reading low.It was noted that the spo2 was reading lower than expected on pts.It was rechecked with another pulse oximeter that gave a reading more in line with the pt's presentation and showed a significant difference.The expected variance was greater than (b)(4).Completed in hospital comparing with another trusted device.Investigation situation: 1.On september 15, 2023, our company received an email notification from the fda to notify the mdr report, and immediately organized an investigation after receipt, and found that the product serial number was not provided in the mdr report, which could not be traced back to the failure of the specific batch of products.Our company immediately contacted the agency who did the report by e-mail, and at the same time contacted the dealer who sold the product by e-mail to inquire about the relevant serial number information and usage; 2.I did not receive any feedback 3 days after the email was sent, and i sent another email to follow up on (b)(6), 2023; 3.On (b)(6), 2023, we received feedback from the customer (the distributor of the product): the serial number information of the product could not be provided, and the customer was arranged to return the same batch of 10pcs inventory products to apk for further investigation and analysis; 4.On (b)(6), we received an email from the customer saying that the failed unit was found, and due to the chinese national day holiday, our company replied to the customer after work on (b)(6), our distributor information and our address, fedex account number, contact person and other information to recieve the product.However, we have not received the defective product and have not received any more emails from customers.5.On (b)(6), 2023, we received (b)(4) of inventory products from the customer (the distributor of the product), and apk conducted accuracy tests on all products, but not able to replicate the issue, and the relevant test records are detailed in appendix 1: fda mdr report of nk-spo2-advt accuracy test record; 6.On (b)(6), 2023, the relevant test data will be sent to the customer(our distributor), indicating that the product returned by the customer can not replicate the issue.In order to further investigate and analyze the product, we have sent an email to communicate with the customer(our distributor) on (b)(6), 2023, requesting assistance in returning the failed unit; 7.As of (b)(6), 2023, no feedback reply from the customer has been received, so we re-sent an email to follow up, urging the defective product to be returned to apk for further investigation and analysis.

• Brand Name: PULSE OXIMETER SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): APK TECHNOLOGY CO., LTD.
• Manufacturer (Section G): APK TECHNOLOGY CO., LTD
• Manufacturer Contact: caifang wang ; 6 floor, building b2, industry of hengfeng,; no. 739, zhoushi road, hezhou, hangcheng street,; shenzhen, ; CH
• MDR Report Key: 18289188
• MDR Text Key: 330829235
• Report Number: 3007699081-2023-00001
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NK-SPO2-ADVT
• Device Catalogue Number: NK-SPO2 ADVT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: MW5145125
• Patient Sequence Number: 1