LIFE SCOPE PT
Report
- Report Number
- 8030229-2023-03954
- Event Type
- Malfunction
- Date Received
- December 26, 2023
- Date of Event
- November 29, 2023
- Report Date
- August 14, 2024
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- UDI-DI
- 04931921111833
- PMA / PMN Number
- K220976
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
UDI RELATED DATA QUALITY UPDATES. CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM BSM-1733A TO LIFE SCOPE PT. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM BSM-1733A TO BSM-1733. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. G4 PREMARKET IDENTIFICATION / PMA/510(K) NUMBER: CORRECTED THE 510(K) # FROM K080342 TO K220976. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A.
DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE RESPIRATORY RATE (RR) VALUE IS CHANGING CONSTANTLY ON THIS DEVICE. ACCORDING TO THE CUSTOMER, THE VALUE WILL DROP TO 0 AND THEN IT GOES BACK UP. THE CUSTOMER HAS TRIED CHANGING OUT THE LEADS AND USED THE SAME LEADS ON A DIFFERENT 1700 UNIT AND THAT UNIT WORKED NORMALLY. THE CUSTOMER WILL SEND IN THE UNIT TO BE EXCHANGED. INVESTIGARTION SUMMARY: NIHON KOHDEN (NK) WAS UNABLE TO CONFIRM THE REPORTED ISSUE AS IT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE. NK WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE, AS THE ISSUE IS USER DEPENDENT. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/13/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING, I DO NOT HAVE ANY PATIENT INFORMATION. B6 ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/13/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING, I DO NOT HAVE ANY PATIENT INFORMATION. B7 ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/13/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING, I DO NOT HAVE ANY PATIENT INFORMATION. D10 ATTEMPT # 1: 12/07/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/13/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: THE CUSTOMER REPLIED BY STATING, I DO NOT HAVE ANY PATIENT INFORMATION. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. D9 IS THIS DEVICE AVAILABLE FOR EVALUATION? G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER? H11 ADDITIONAL MANUFACTURER NARRATIVE. MANUFACTURER REFERENCES # (B)(4).
THE CUSTOMER REPORTED THAT THE RESPIRATORY RATE (RR) VALUE IS CHANGING CONSTANTLY ON THIS DEVICE. ACCORDING TO THE CUSTOMER, THE VALUE WILL DROP TO 0 AND THEN IT GOES BACK UP. THE CUSTOMER HAS TRIED CHANGING OUT THE LEADS AND USED THE SAME LEADS ON A DIFFERENT 1700 UNIT AND THAT UNIT WORKED NORMALLY. THE CUSTOMER WILL SEND IN THE UNIT TO BE EXCHANGED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THE CUSTOMER REPORTED THAT THE RESPIRATORY RATE (RR) VALUE IS CHANGING CONSTANTLY ON THIS DEVICE. THERE WAS NO PATIENT INJURY REPORTED.
THE CUSTOMER REPORTED THAT THE RESPIRATORY RATE (RR) VALUE IS CHANGING CONSTANTLY ON THIS DEVICE. THERE WAS NO PATIENT INJURY REPORTED.
THE CUSTOMER REPORTED THAT THE RESPIRATORY RATE (RR) VALUE IS CHANGING CONSTANTLY ON THIS DEVICE. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1361379 | LIFE SCOPE PT | TRANSPORT MONITOR, MASIMO SPO2 | MHX | NIHON KOHDEN CORPORATION | BSM-1733 | NA | 04931921111833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |