MAUDE Adverse Event Report: ST PAUL BCI WW1000 PULSE OXIMETER

Model Number	WW1000A1EN
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.It was visually inspected, and it was in good condition with no damage or defects noted.Functional test sp02 was performed on the returned device with the customer?s sensor (which was not the sensor of concern); as well as, with the manufacture?s test-sensor.Both values were valid, no difference was found, stable readings as expected.The investigation could not confirm the problem in this case because the unit was not tested using a ww3078 ear probe the customer was concerned about.Previous investigation of the same issue on prior complaint confirmed the ear probes to be malfunctioning and causing erratic reading but the ww1000's spectro2 are operating as intended when spo2 probes other than ear probes are used.This was a known failure- malfunctioning ear probes as result of photodetector's sensitivity to noises causing erratic readings; and is isolated to the use of ww3078 / v3078 ear probes with the monitor.A non-conforming event has been elevated.A device history record review (dhr) was not applicable in this case because the defective ww3078 ear probe is not evaluated or tested in any way during the manufacturing process at this manufacturer and the ww3078 manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that the device had erratic reading with three main issues: the size of the ear probe was too big and proved difficult to position properly.Ear and finger readings were at least 2 percent different, new pleth was tried, but to no avail.Several devices in the community team same had the same issue.The readings did not marry up with those taken using the ward high dependency monitor ear pleths.No patient injury was reported.

• Brand Name: BCI WW1000 PULSE OXIMETER
• Common Device Name: 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: 15445136
• Report Number: 3012307300-2022-19587
• Device Sequence Number: 4729227
• Product Code: DQA
• UDI-Device Identifier: 30843418000283
• UDI-Public: 30843418000283
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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 Model Number: WW1000A1EN
• Device Catalogue Number: WW1000A1EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown