GZ-130P
Report
- Report Number
- 8030229-2023-03692
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Date of Event
- July 14, 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
- OK, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TELEMETRY TRANSMITTER OVERHEATED. THE BME TRIED CHANGING THE BATTERIES AND THE SETTINGS IN ATTEMPT TO LOWER THE TEMPERATURE, BUT THE ISSUE PERSISTED. IT WAS UNKNOWN IF THE DEVICE WAS IN PATIENT USE. INVESTIGATION SUMMARY: A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED DUE TO THE LACK OF RESPONSE FROM THE CUSTOMER. WITHOUT THE ROOT CAUSE, COUNTERMEASURES TO PREVENT RECURRENCE OF THE ISSUE COULD NOT BE IMPLEMENTED. NK WILL CONTINUE TO TREND AND MONITOR THE REPORTED ISSUE. NO CORRECTIVE ACTIONS WILL BE PERFORMED AT THIS TIME.
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 TELEMETRY TRANSMITTER IS EXPERIENCING OVERHEATING. THE BME TRIED TO CHANGE SETTINGS IN ATTEMPT TO LOWER TEMPERATURE OR TRIED CHANGING BATTERIES. HOWEVER, THE PROBLEM STILL PERSISTS. IT IS UNKNOWN IF THE DEVICE WAS IN PATIENT USE. 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 FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: A2 - A6. B6 - B7. D4 LOT NUMBER & EXPIRATION. D6A - D6B. D10 CONCOMITANT MEDICAL DEVICE. F1 - F14. G4 DEVICE BLA NUMBER.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TELEMETRY TRANSMITTER OVERHEATED. THE BME TRIED CHANGING THE BATTERIES AND THE SETTINGS IN ATTEMPT TO LOWER THE TEMPERATURE, BUT THE ISSUE PERSISTED. IT WAS UNKNOWN IF THE DEVICE WAS IN PATIENT USE.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TELEMETRY TRANSMITTER OVERHEATED. THE BME TRIED CHANGING THE BATTERIES AND THE SETTINGS IN ATTEMPT TO LOWER THE TEMPERATURE, BUT THE ISSUE PERSISTED. IT WAS UNKNOWN IF THE DEVICE WAS IN PATIENT USE.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TELEMETRY TRANSMITTER IS EXPERIENCING OVERHEATING. THE BME TRIED TO CHANGE SETTINGS IN ATTEMPT TO LOWER TEMPERATURE OR TRIED CHANGING BATTERIES. HOWEVER, THE PROBLEM STILL PERSISTS. IT IS UNKNOWN IF THE DEVICE WAS IN PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2243658 | GZ-130P | TRANSMITTER | MHX | NIHON KOHDEN CORPORATION | GZ-130P | NA | 04931921117415 |
| 2333887 | GZ-130P | TRANSMITTER | MHX | NIHON KOHDEN CORPORATION | GZ-130P | NA | 04931921117415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NI.| NI.| NI. |