MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED EMBLETTA MPR PG; EMBLETTA MPR PG,

Model Number 2003011

Device Problems Failure to Power Up (1476); Power Problem (3010)

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

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

Initial report ref to natus (b)(4).Lot / serial to be confirmed.Technical service was contacted to send the customer an adverse event questionnaire.The email also requested to have the customer send the affected device back to natus for investigation.Per qms-004442, complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Further investigation to be carried out.

Event Description

Part embletta mpr pg -: spo2 not recording on mpr device.The pulse oximeter during patient's home sleep study failed to turn on for the patient at home.Patient did wear the home sleep test, but because there was no oximetry reading the patient had to repeat the test.

Manufacturer Narrative

Follow up report 001 ref to natus complaint# (b)(4).(related to uf/importer report# (b)(4).That was received through fda's medsun program).Product examination and functional testing: 08-aug-2023: medwatch form (uf/importer report# (b)(4) stated that the device was returned to the manufacturer on july 6th 2023.No lot or serial number was provided, and natus was unable to confirm return of device.No return of device despite multiple attempts made to the customer on aug 15th, 21st, 28th and sept 5th 2023.This complaint does not identify a deficiency in the product design and therefore a capa is not required.Acceptable risk as per hazard id 5.39 in (b)(4) embla risk analysis.Risk is considered to be low.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.Closure rationale: complaint verified, being tracked as a trend.Complaint will be included in trending data for further review.

Event Description

Part embletta mpr pg -: spo2 not recording on mpr device.The pulse oximeter during patient's home sleep study failed to turn on for the patient at home.Patient did wear the home sleep test, but because there was no oximetry reading the patient had to repeat the test.

• Brand Name: EMBLETTA MPR PG
• Type of Device: EMBLETTA MPR PG,
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontario l6h 5s1, ; CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: grainne walsh ; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontario l6h 5s1, ; CA
• MDR Report Key: 17547562
• MDR Text Key: 321138864
• Report Number: 9612330-2023-00023
• Device Sequence Number: 1
• Product Code: MNR
• UDI-Device Identifier: 00382830023764
• UDI-Public: 00382830023764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Model Number: 2003011
• Device Catalogue Number: 2003011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1