GZ-130P
Report
- Report Number
- 8030229-2023-03685
- Event Type
- Malfunction
- Date Received
- July 24, 2023
- Date of Event
- June 27, 2023
- Report Date
- August 12, 2024
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- UDI-DI
- 04931921117415
- PMA / PMN Number
- K153707
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER BATTERIES WERE DRAINING WITHIN TWO (2) HOURS AND THE DEVICE DID NOT GIVE AN ALARM INDICATING THE BATTERY WAS LOW. THEY STATED THE BATTERIES WERE NEW AND HAD THE SAME SETTINGS AS A WORKING GZ TRANSMITTER. NO REPORTS OF PATIENT HARM OR INJURIES. INVESTIGATION SUMMARY: NIHON KOHDEN RECEIVED THE DEVICE ON 07/28/2023. NK REPAIR CENTER EVALUATED THE DEVICE ON 10/23/2023 AND DUPLICATED THE COMPLAINT. THE UNIT WAS TESTED WITH TWO NEW BATTERIES, AND IT DRAINED FAST. NK RC FOUND THAT THE BATTERY CONTACTS WERE CORRODED AND THE ECG AND SPO2 PORTS WERE DIRTY. BASED ON THE DEVICE EVALUATION, THE CAUSE OF THE ISSUE WAS A LACK OF PROPER MAINTENANCE OF THE TRANSMITTER. THE GZ-130P OPERATOR'S MANUAL STATES THAT IF THE DEVICE IS NOT GOING TO BE USED FOR AN EXTENDED PERIOD, THE USER SHOULD REMOVE THE BATTERIES BEFORE STORING THE DEVICE TO PREVENT BATTERY LEAKAGE. A REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER SHOWS NO OTHER COMPLAINT. A REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY DID NOT REVEAL ANY TRENDS. NK WILL CONTINUE TO MONITOR AND TREND SIMILAR COMPLAINTS. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER:
UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM GZ-130PA TO GZ-130P. D2B PRODUCT CODE: CORRECTED THE PRODUCT CODE FROM DRT TO MHX. D4 ADDITIONAL DEVICE INFORMATION / MODEL #: CORRECTED THE MODEL # FROM GZ-130PA TO GZ-130P. D4 ADDITIONAL DEVICE INFORMATION / CATALOG #: CORRECTED THE CATALOG # FROM GZ-130PA TO GZ-130P. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. 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, PER THE FDA REQUEST. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE?
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER BATTERIES WERE DRAINING WITHIN TWO (2) HOURS AND THE DEVICE DID NOT GIVE AN ALARM INDICATING THE BATTERY WAS LOW. THEY STATED THE BATTERIES WERE NEW AND HAD THE SAME SETTINGS AS A WORKING GZ TRANSMITTER. NO REPORTS OF PATIENT HARM OR INJURIES. 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: 07/18/2023 EMAILED THE BME FOR PATIENT INFORMATION AND THE CONCOMITANT MEDICAL DEVICE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 07/21/2023 EMAILED THE BME FOR PATIENT INFORMATION AND THE CONCOMITANT MEDICAL DEVICE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 07/24/2023 EMAILED THE BME FOR PATIENT INFORMATION AND THE CONCOMITANT MEDICAL DEVICE: NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CNS: MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER BATTERIES WERE DRAINING WITHIN TWO (2) HOURS AND THE DEVICE DID NOT GIVE AN ALARM INDICATING THE BATTERY WAS LOW. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER BATTERIES WERE DRAINING WITHIN TWO (2) HOURS AND THE DEVICE DID NOT GIVE AN ALARM INDICATING THE BATTERY WAS LOW. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER BATTERIES WERE DRAINING WITHIN TWO (2) HOURS AND THE DEVICE DID NOT GIVE AN ALARM INDICATING THE BATTERY WAS LOW. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2333885 | GZ-130P | TRANSMITTER | MHX | NIHON KOHDEN CORPORATION | GZ-130P | NA | 04931921117415 |
| 597791 | GZ-130P | TRANSMITTER | MHX | NIHON KOHDEN CORPORATION | GZ-130P | NA | 04931921117415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | CNS.| CNS.| CNS. |