GZ-130PA
Report
- Report Number
- 8030229-2024-04277
- Event Type
- Malfunction
- Date Received
- May 21, 2024
- Date of Event
- April 22, 2024
- Report Date
- January 23, 2025
- 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
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE GZ TRANSMITTER NEVER ALARMED FOR LOW BATTERY BEFORE THE BATTERY DIED. ACCORDING TO THE CUSTOMER, THE BATTERIES BEING USED ARE PROCELL INTENSE. THE CUSTOMER REQUESTED FOR THE LOGS TO BE INVESTIGATED TO SEE WHY IT DID NOT ALARM. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: THE DEVICE LOGS WERE COLLECTED AND REVIEWED BY NKC. NKC WAS UNABLE TO CONFIRM THE REPORTED ISSUE DURING THE TIME OF THE EVENT DUE TO THE LOGS NOT REVEALING ANY CLEAR "BATTERY WEAK" ERROR MESSAGES. UNFORTUNATELY, THE LOGS DID NOT REVEAL ANY CLEAR CAUSES OF THE REPORTED ISSUE AND NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. ADDITIONAL MODEL INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CNS: MODEL #: PU-681RA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATE: 12/13/2021, UNIQUE IDENTIFIER (UDI) #: (B)(4) AND RETURNED TO NIHON KOHDEN: NO. D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: G9 MONITOR: MODEL #: CU-192RA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATE: 10/25/2018, UNIQUE IDENTIFIER (UDI) #: (B)(4) AND RETURNED TO NIHON KOHDEN: NO. CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM GZ-130PA TO GZ-130P. D2B DEVICE 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 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. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT, D1 BRAND NAME, D2B DEVICE PRODUCT CODE, D4 MODEL NUMBER, D4 CATALOG NUMBER, D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, G6 TYPE OF REPORT, H2 IF FOLLOW UP, WHAT TYPE? AND H11 ADDITIONAL MANUFACTURER NARRATIVE.
THE CUSTOMER REPORTED THAT THE GZ TRANSMITTER NEVER ALARMED FOR LOW BATTERY BEFORE THE BATTERY DIED. ACCORDING TO THE CUSTOMER, THE BATTERIES BEING USED ARE PROCELL INTENSE. THE CUSTOMER REQUESTED FOR THE LOGS TO BE INVESTIGATED TO SEE WHY IT DID NOT ALARM. THERE WAS NO PATIENT INJURY 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. ADDITIONAL MODEL INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CNS: MODEL #: PU-681RA SERIAL #:(B)(6). DEVICE MANUFACTURER DATE: 12/13/2021 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NO. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: MODEL #: CU-192RA SERIAL #: (B)(6). DEVICE MANUFACTURER DATE: 10/25/2018. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NO.
DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE GZ TRANSMITTER NEVER ALARMED FOR LOW BATTERY BEFORE THE BATTERY DIED. ACCORDING TO THE CUSTOMER, THE BATTERIES BEING USED ARE PROCELL INTENSE. THE CUSTOMER REQUESTED FOR THE LOGS TO BE INVESTIGATED TO SEE WHY IT DID NOT ALARM. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: THE DEVICE LOGS WERE COLLECTED AND REVIEWED BY NKC. NKC WAS UNABLE TO CONFIRM THE REPORTED ISSUE DURING THE TIME OF THE EVENT DUE TO THE LOGS NOT REVEALING ANY CLEAR "BATTERY WEAK" ERROR MESSAGES. UNFORTUNATELY, THE LOGS DID NOT REVEAL ANY CLEAR CAUSES OF THE REPORTED ISSUE AND NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. ADDITIONAL MODEL INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CNS: MODEL #: PU-681RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATE: 12/13/2021. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NO. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: MODEL #: CU-192RA SERIAL #: (B)(6). DEVICE MANUFACTURER DATE: 10/25/2018 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NO. ADDITIONAL INFORMATION: DATE OF THIS REPORT. DATE RECEIVED BY MANUFACTURER. TYPE OF REPORT. IF FOLLOW UP, WHAT TYPE? MANUFACTURER REFERENCES # (B)(4) FOLLOW UP 001.
THE CUSTOMER REPORTED THAT THE GZ TRANSMITTER NEVER ALARMED FOR LOW BATTERY BEFORE THE BATTERY DIED. THERE WAS NO PATIENT INJURY REPORTED.
THE CUSTOMER REPORTED THAT THE GZ TRANSMITTER NEVER ALARMED FOR LOW BATTERY BEFORE THE BATTERY DIED. THERE WAS NO PATIENT INJURY REPORTED.
THE CUSTOMER REPORTED THAT THE GZ TRANSMITTER NEVER ALARMED FOR LOW BATTERY BEFORE THE BATTERY DIED. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515674 | GZ-130PA | TRANSMITTER | MHX | NIHON KOHDEN CORPORATION | GZ-130P | NA | 04931921117415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | CNS/PU-681RA| CNS/PU-681RA| CNS/PU-681RA| G9/CU-192RA| G9/CU-192RA| G9/CU-192RA |