MAUDE Adverse Event Report: ST PAUL SPECTRO2 10 PULSE OXIMETER EAR SENSOR

Catalog Number WW3078

Device Problems Ambient Noise Problem (2877); Erratic Results (4059)

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

Event Type  malfunction  

Event Description

It was reported that fluctuations were found during use of the ear sensor.The engineer tested it with another sensor and it worked fine.No patient was involved.

Manufacturer Narrative

Udi information is unknown.Samples were received to perform an investigation.Upon visual inspection, no physical damage or defect was noted.Spo2 tests were performed using the returned ear probes and the customer's oximeters.A set of known good ear probes from different lots and a v3078 ear probe from 2012 were tested with the returned oximeters.Checked spo2 reading using finger probes including a known good 3044 probe and a known good 3178 pediatric finger sensor and the reported problem was duplicated.It was determined that the noted interferences are attenuated in monitors built with digital spo2 boards but not with those built with analog spo2 board.The reported erratic reading was confirmed and isolated to the ww3078 ear probes.The returned spectr02 10 pulse oximeter was found to be operating as intended and acquired readings accurately within specification when tested.However, when any ear probes whether from the returned samples or the known inhouse tests ear probes were connected, the monitor would detect a pulse even with no patient attached and randomly displayed heart rate readings when the cable was manipulated or curled by the rubber stop near the clips.The same probes were attached to a bci multiparameter advisor and each of the ear probes connected acted similarly by generating pulses with no test subjected connected.Further evaluation determined that when flapping the clips constantly in an open and close movement, the advisor monitor consistently detected and displayed a heart rate.Evidence of noise interfering with the emitter and the detector signal which contributed to the customer's observed failure of erratic and erroneous reading.It was concluded that the detector in the 3078 ear probes may have been malfunctioning all these times.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: SPECTRO2 10 PULSE OXIMETER EAR SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15327620
• MDR Text Key: 305419855
• Report Number: 3012307300-2022-17012
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: WW3078
• Device Lot Number: 1942-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1