EMBLETTA MPR PG

Description of Event or Problem

EMBLETTA MPR PG OVERHEATED. NO INJURY OR DEATH.

Additional Manufacturer Narrative

FOLLOW UP REPORT 002 REF NATUS COMPLAINT# (B)(4). A REPLACEMENT EMBLETTA MPR PG (SN (B)(6)) WAS SHIPPED TO THE CUSTOMER. AUG-08-2021 THE TECHNICAL SERVICE REPORTED THE 2 EMBLETTA MPRS AND OXIMETERS HAD NOT BEEN RETURNED. THE TECHNICAL SERVICE REPRESENTATIVE REACHED OUT TO HAVE ALL AFFECTED ITEMS RETURNED. AUG-12-2021 THE SALES REPRESENTATIVE REPORTED THAT THE DISTRIBUTOR REPORTED THAT THEY ARE STILL USING THE AFFECTED EMBLETTA MPRS AND THEY "ARE WORKING NORMALLY." THEY STATED THE CUSTOMER CANNOT RETURN BOTH UNITS AND NEED TO RETURN THE REPLACEMENTS. AUG-13-2021 THE SERVICE TECHNICAN EMAILED A 2ND REQUEST FOR THE UNITS TO BE RETURNED FOR INVESTIGATION. JAN-21-2022 3RD REQUEST FOR RETURN OF THE DEFECTIVE UNIT. MAR-08-2022 IT HAS BEEN MORE THAN 45 DAYS SINCE THE LAST RMA SENT TO THE CUSTOMER. PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION, THEREFORE UNABLE TO VERIFY COMPLAINT. COMPLAINT WILL BE INCLUDED IN THE TRENDING DATA FOR FURTHER REVIEW PER QMS-004442. DHR REVIEW: JUN-22-2020. INSTALL DATE: SEP-16-2020.

Description of Event or Problem

EMBLETTA MPR PG OVERHEATED. NO INJURY OR DEATH.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). THE AFFECTED PRODUCT TO BE RETURNED FOR INVESTIGATION. THE AFFECTED PRODUCT HAS NOT BEEN RETURNED TO DATE. CORRECTION TO SECTION B1., H1., SECTION D4., INCLUDED UNIQUE IDENTIFIER (UDI): (B)(4).

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). PART 2003011 SERIAL (B)(4) EMBLETTA MPR PG OVERHEATED. DURING THE ACQUISITION PROCESS OF DEVICE, THE DATA WAS ABNORMALLY INTERRUPTED AND THERE WAS NO WAVEFORM, BUT THE DATA DURATION WAS 8 HOURS. THE CUSTOMER REPORTED A FAILURE A FEW DAYS AGO, SAYING THAT THE DEVICE WAS HEATING UP SEVERELY, BUT STOPPED HEATING FOR UNKNOWN REASONS. THE CUSTOMER REPORTED NO SMOKE, FLAMES OR MELTING OF THE ENCLOSURE. THEY STATED THE RECORD WAS ABNORMAL, THE PATIENT FOUND THE LOCATION ABOVE THE BATTERY COVER GETTING HOT. THE CUSTOMER STOPPED THE COLLECTION FOR THE NIGHT. THE AFFECTED PRODUCT IS REQUESTED TO BE RETURNED FOR INVESTIGATION. (B)(4) REV 16 RISK ANALYSIS: HAZARD ID 2.2 - FAILURE OF ELECTRONIC COMPONENT. EFFECTS (HARM) - RANGE FROM CLINICALLY INSIGNIFICANT TO MINOR INJURY FROM BURNS. RESIDUAL RISK= MEDIUM AND ACCEPTABLE. THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISK FOR THESE HAZARDS ARE CATEGORIZED AS HAVING AN RBA RATING OF MEDIUM DUE TO THE NATURE OF THE HAZARD. HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN DESIGN CONTROL CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE.

Description of Event or Problem

EMBLETTA MPR PG OVERHEATED. NO INJURY OR DEATH.