EMBLETTA MPR PG
Report
- Report Number
- 9612330-2021-00006
- Event Type
- Malfunction
- Date Received
- July 8, 2021
- Date of Event
- June 26, 2021
- Report Date
- March 9, 2022
- Manufacturer
- NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
- Product Code
- OLV
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
FOLLOW UP REPORT 002 REF NATUS COMPLAINT# (B)(6). AWAITING RETURN OF THE AFFECTED PRODUCT. CORRECTION TO SECTION B1., H1., SECTION D4., INCLUDED UNIQUE IDENTIFIER (UDI).
FOLLOW UP REPORT 003 REF NATUS COMPLAINT# (B)(4). A REPLACEMENT EMBLETTA MPR PG (SN (B)(6)) WAS SHIPPED TO THE CUSTOMER. (B)(6) 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. (B)(6) 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. (B)(6) 2021: THE SERVICE TECHNICAN EMAILED A 2ND REQUEST FOR THE UNITS TO BE RETURNED FOR INVESTIGATION. (B)(6) 2022: 3RD REQUEST FOR RETURN OF THE DEFECTIVE UNIT. (B)(6) 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 (B)(4). ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 2.2 IN (B)(4) EMBLA RISK ANALYSIS SPREADSHEET. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. INSTALL DATE: (B)(6) 2020.
FOLLOW UP REPORT REF NATUS COMPLAINT# (B)(4). CORRECTION: H3 UPDATED TO INDICATE DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. FOLLOW UP 001. B3: DATE OF EVENT UPDATED. THE CUSTOMER REPORTED THAT THE ACTUAL EVENT OCCURRED ON (B)(6) 2021 TO 3 PATIENTS AND THE ALL WERE INTERRUPTED AROUND 1:00 AM OR 2:00 AM FOR A TOTAL OF 8 HOURS BUT THE UNITS SHOW A STRAIGHT LINE, INDICATING DEACTIVATION.
EMBLETTA MPR PG OVERHEATED. NO INJURY OR DEATH.
EMBLETTA MPR PG OVERHEATED. NO INJURY OR DEATH.
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. PER DOC (B)(4). REV 16 RISK ANALYSIS HAZARD ID 6.3 - PULSE OX SENSOR OVERHEATS OR IS TOO HOT FOR PATIENT CONTACT. EFFECTS (HARM) - RANGE FROM CLINICALLY INSIGNIFICANT TO IRREVERSIBLE INJURY RESULTING FROM DIRECT PHYSICAL INJURY RESIDUAL RISK= LOW AND ACCEPTABLE THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS (B)(4), HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS 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.
EMBLETTA MPR PG OVERHEATED. NO INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1034352 | EMBLETTA MPR PG | EMBLETTA MPR PG | OLV | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. | 2003011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |