LIFE SCOPE PT
Report
- Report Number
- 8030229-2023-03938
- Event Type
- Malfunction
- Date Received
- December 8, 2023
- Date of Event
- November 10, 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
- VA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR'S (BSM) ON/OFF SWITCH WAS NOT WORKING. THEY HAD TO REMOVE THE BATTERY FROM THE UNIT WHEN IT WAS POWERED ON TO POWER IT OFF AND WERE UNABLE TO POWER IT BACK ON. THE DEVICE DID NOT DISPLAY AN ERROR MESSAGE. NO PATIENT HARM OR INJURIES WERE REPORTED. 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. ATTEMPT # 1: 11/14/2023 EMAILED THE BME FOR ALL ITEMS UNDER THE NO INFORMATION LIST. THE BME REPLIED THEY DID NOT KNOW THE PATIENT INFORMATION. ATTEMPT # 2: 12/04/2023 EMAILED THE BME FOR ANY CONCOMITANT MEDICAL DEVICE(S) USED: NO REPLY WAS RECEIVED. ATTEMPT # 3: 12/07/2023 EMAILED THE BME FOR ANY CONCOMITANT MEDICAL DEVICE(S) USED: NO REPLY WAS RECEIVED.
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. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE?
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR'S (BSM) ON/OFF SWITCH WAS NOT WORKING. THEY HAD TO REMOVE THE BATTERY FROM THE UNIT WHEN IT WAS POWERED ON TO POWER IT OFF AND WERE UNABLE TO POWER IT BACK ON. THE DEVICE DID NOT DISPLAY AN ERROR MESSAGE. NO PATIENT HARM OR INJURIES WERE REPORTED. INVESTIGATION SUMMARY: THE REPORTED ISSUE WAS DUPLICATED AND CONFIRMED. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. UPON EVALUATION FROM THE REPAIR CENTER, THEY FOUND THAT THE CABLE (UR-4243-01) THAT CONNECTS TO THE POWER SUPPLY WAS DISCONNECTED. ONCE THE REPAIR CENTER CONNECTED THE POWER CABLE, THE POWER BUTTON WORKED PROPERLY WITHOUT ANY ISSUES. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONTRIBUTED TO THE UNIT BEING DROPPED OR EXCESSIVE FORCE (PHYSICAL DAMAGE) WHICH MADE THE CABLE COME LOOSE. POSSIBLE CAUSES OF PHYSICAL DAMAGE INCLUDE THE BEDSIDE MONITOR BEING DESIGNED TO BE MOBILE AND TRAVEL WITH THE PATIENT DURING TRANSPORT. THE POSSIBILITY OF IMPACT IS SIGNIFICANTLY INCREASED IN THESE DEVICES BECAUSE OF THEIR MOBILE STATUS. ACCORDING TO THE OPERATOR'S MANUAL, BEFORE TURNING ON THE POWER AND AFTER OR BEFORE TURNING THE POWER OFF, THE USER NEEDS TO ENSURE THAT THERE ARE NO SCRATCHES, DAMAGE, DETERIORATION, DIRT, OR OTHER CONTAMINANTS ON THE MONITOR. DEVICE INSTALLATION AND SAFE HANDLING USAGE HAVE BEEN PROVIDED TO THE USER VIA THE OPERATOR'S MANUAL. A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. A COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL TRENDS FOR SIMILAR COMPLAINTS. NK WILL CONTINUE TO MONITOR AND TREND SIMILAR COMPLAINTS. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT # 1: (B)(6) 2023 EMAILED THE BME FOR ALL ITEMS UNDER THE NO INFORMATION LIST. THE BME REPLIED THEY DID NOT KNOW THE PATIENT INFORMATION. ATTEMPT # 2: (B)(6) 2023 EMAILED THE BME FOR ANY CONCOMITANT MEDICAL DEVICE(S) USED: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2023 EMAILED THE BME FOR ANY CONCOMITANT MEDICAL DEVICE(S) USED: NO REPLY WAS RECEIVED. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. D9 DEVICE AVAILABLE FOR EVALUATION. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER. H6 EVENT PROBLEM AND EVALUATION CODES. H11 ADDITIONAL MANUFACTURER NARRATIVE.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR'S (BSM) ON/OFF SWITCH WAS NOT WORKING. THEY HAD TO REMOVE THE BATTERY FROM THE UNIT WHEN IT WAS POWERED ON TO POWER IT OFF AND WERE UNABLE TO POWER IT BACK ON. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR'S (BSM) ON/OFF SWITCH WAS NOT WORKING. THEY HAD TO REMOVE THE BATTERY FROM THE UNIT WHEN IT WAS POWERED ON TO POWER IT OFF AND WERE UNABLE TO POWER IT BACK ON. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR'S (BSM) ON/OFF SWITCH WAS NOT WORKING. THEY HAD TO REMOVE THE BATTERY FROM THE UNIT WHEN IT WAS POWERED ON TO POWER IT OFF AND WERE UNABLE TO POWER IT BACK ON. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222523 | LIFE SCOPE PT | TRANSPORT MONITOR, MASIMO SPO2 | MHX | NIHON KOHDEN CORPORATION | BSM-1733 | NA | 04931921111833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |