MAUDE Adverse Event Report: JABIL CIRCUIT SHANGHAI LTD MULTI-FUNCTIONAL RESPIRATORY P; OXIMETER

Model Number PMB05N

Device Problems Incorrect Measurement (1383); Communication or Transmission Problem (2896)

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

Event Date 06/30/2023

Event Type  malfunction  

Event Description

According to the reporter, during use, the unit lights appeared to be interfering with the sensor readings. when the device was on and the sensor was below the light, it gave false readings.The solution was to cover the sensor to block the excess light to avoid the interference, and able to obtained an accurate reading. there was no patient injury.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that there was an issue with the firmware.It was reported that the monitor provided incorrect readings but it was not stated if the readings were too high or low and the product did not send communications.The reported issues were confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.This report is being submitted as part of a retrospective review and remediation per crp no.1000199834/nc36.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MULTI-FUNCTIONAL RESPIRATORY P
• Type of Device: OXIMETER
• Manufacturer (Section D): JABIL CIRCUIT SHANGHAI LTD; no 600 tian lin rd; shanghai 20023 3; CH 200233
• Manufacturer (Section G): JABIL CIRCUIT SHANGHAI LTD; no 600 tian lin rd; shanghai 20023 3; CH 200233
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18697314
• MDR Text Key: 335266320
• Report Number: 2936999-2024-00309
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PMB05N
• Device Catalogue Number: PMB05N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2024
• 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
• Patient Sequence Number: 1