GZ-130PA
Report
- Report Number
- 8030229-2023-03582
- Event Type
- Malfunction
- Date Received
- June 12, 2023
- Date of Event
- May 16, 2023
- Report Date
- September 12, 2023
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- DRT
- 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 BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSES ARE TELLING HIM THAT THE GZ MONITOR IS NOT ALARMING LOW BATTERY AT THE CNS. THE BME STATES THE NURSES REPORTED THEY NEVER GET AN ALARM AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A REGULAR GZ AND NOT BEING USED IN HI-Q. NO PATIENT INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE GZ-130PA DEVICE WAS RECEIVED TO NIHON KOHDEN REPAIR CENTER (NKRC) ON 06/14/2023. NK REPAIR CENTER (RC) EVALUATED THE DEVICE ON 09/07/2023 AND COULD NOT DUPLICATE THE COMPLAINT. THE UNIT WAS TESTED PER THE OPERATOR'S MANUAL AND ADMINISTRATOR'S GUIDE BUT NO PROBLEM WAS FOUND. REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER SHOWS THAT IT IS OVER 1 YEAR OLD AND HAS NO PREVIOUS OCCURRENCE OF THIS ISSUE. AN INVESTIGATION WAS PERFORMED BY NIHON KOHDEN CORPORATION (NKC) WHICH FOUND THAT THE DEVICE MOST LIKELY SHUT DOWN FROM POWER LOSS BEFORE IT COULD GENERATE COMMUNICATION OF THE LOW/WEAK BATTERY STATUS. THIS ISSUE OF 'NO ALARM FOR LOW BATTERY' FOR THIS CUSTOMER WAS INVESTIGATED BY NKC WHICH CONFIRMED THAT THE CUSTOMER IS USING BATTERIES NOT RECOMMENDED FOR USE WITH THE GZ TRANSMITTER. FROM REVIEW OF DEVICE LOGS FROM SIMILAR REPORTED COMPLAINTS FOR THIS CUSTOMER NKC FOUND THAT THE DEVICE MOST LIKELY SHUT DOWN FROM POWER LOSS BEFORE IT COULD GENERATE COMMUNICATION OF THE LOW/WEAK BATTERY STATUS. THE GZ OPERATOR'S MANUAL RECOMMENDS USING MEDIPOWER ALKALINE BATTERIES OR PANASONIC NIMH BATTERIES. NK FIELD SUPPORT ENGINEER/ACCOUNT MANAGER REPORTED THAT THE CUSTOMER HAS SWITCHED FROM USING PROCELL CONSTANT TO PROCELL INTENSE BATTERIES. THIS WILL CONTINUE TO BE MONITORED BY NK. THE FOLLOWING FIELD(S) CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6 B6 B7 D10 ATTEMPT # 1: 06/05/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 06/12/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ADDITIONAL INFORMATION: E1 INITIAL REPORTER INFORMATION. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW UP, WHAT TYPE? H10 ADDITIONAL MANUFACTURER NARRATIVE. CORRECTION TO INVESTIGATION SUMMARY. MANUFACTURER REFERENCES# (B)(4) FOLLOW UP 002.
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSES ARE TELLING HIM THAT THE GZ MONITOR IS NOT ALARMING LOW BATTERY AT THE CNS. THE BME STATES THE NURSES REPORTED THEY NEVER GET AN ALARM AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A REGULAR GZ AND NOT BEING USED IN HI-Q. NO PATIENT INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE GZ-130PA DEVICE WAS RECEIVED TO NIHON KOHDEN REPAIR CENTER (NKRC) ON 06/14/2023. NK REPAIR CENTER (RC) EVALUATED THE DEVICE ON 09/07/2023 AND COULD NOT DUPLICATE THE COMPLAINT. THE UNIT WAS TESTED PER THE OPERATOR'S MANUAL AND ADMINISTRATOR'S GUIDE BUT NO PROBLEM WAS FOUND. REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER SHOWS THAT IT IS OVER 1 YEAR OLD AND HAS NO PREVIOUS OCCURRENCE OF THIS ISSUE. AN INVESTIGATION WAS PERFORMED BY NIHON KOHDEN CORPORATION (NKC) WHICH FOUND THAT THE DEVICE MOST LIKELY SHUT DOWN FROM POWER LOSS BEFORE IT COULD GENERATE COMMUNICATION OF THE LOW/WEAK BATTERY STATUS. THIS ISSUE OF 'NO ALARM FOR LOW BATTERY' FOR THIS CUSTOMER WAS INVESTIGATED BY NKC WHICH CONFIRMED THAT THE CUSTOMER IS USING BATTERIES NOT RECOMMENDED FOR USE WITH THE GZ TRANSMITTER. FROM REVIEW OF DEVICE LOGS FROM SIMILAR REPORTED COMPLAINTS FOR THIS CUSTOMER NKC FOUND THAT THE DEVICE MOST LIKELY SHUT DOWN FROM POWER LOSS BEFORE IT COULD GENERATE COMMUNICATION OF THE LOW/WEAK BATTERY STATUS. THE GZ OPERATOR'S MANUAL RECOMMENDS USING MEDIPOWER ALKALINE BATTERIES OR PANASONIC NIMH BATTERIES. NK FIELD SUPPORT ENGINEER/ACCOUNT MANAGER REPORTED THAT THE CUSTOMER HAS SWITCHED FROM USING PROCELL CONSTANT TO PROCELL INTENSE BATTERIES. THE CUSTOMER'S COMPLAINT HISTORY SHOWS THAT RECURRENCE OF THIS ISSUE FOR THE GZ TRANSMITTER HAS NOT BEEN REPORTED SINCE INVESTIGATION WAS CLOSED. THIS WILL CONTINUE TO BE MONITORED BY NK. THE FOLLOWING FIELD(S) CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6 B6 B7 D10 ATTEMPT # 1: 06/05/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 06/12/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: 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 ADVERSE EVENT CODES H10 ADDITIONAL MANUFACTURER NARRATIVE MANUFACTURER REFERENCES# (B)(4)FOLLOW UP 001
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSES ARE TELLING HIM THAT THE GZ MONITOR IS NOT ALARMING LOW BATTERY AT THE CNS. THE BME STATES THE NURSES REPORTED THEY NEVER GET AN ALARM AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A REGULAR GZ AND NOT BEING USED IN HI-Q. NO PATIENT INJURY WAS 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. THE FOLLOWING FIELD(S) CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A2 - A6. B6. B7. D10. ATTEMPT # 1: 06/05/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 06/12/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: NO REPLY WAS RECEIVED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSES ARE TELLING HIM THAT THE GZ MONITOR IS NOT ALARMING LOW BATTERY AT THE CNS. THE BME STATES THE NURSES REPORTED THEY NEVER GET AN ALARM AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A REGULAR GZ AND NOT BEING USED IN HI-Q. NO PATIENT INJURY WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSES ARE TELLING HIM THAT THE GZ MONITOR IS NOT ALARMING LOW BATTERY AT THE CNS. THE BME STATES THE NURSES REPORTED THEY NEVER GET AN ALARM AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A REGULAR GZ AND NOT BEING USED IN HI-Q. NO PATIENT INJURY WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSES ARE TELLING HIM THAT THE GZ MONITOR IS NOT ALARMING LOW BATTERY AT THE CNS. THE BME STATES THE NURSES REPORTED THEY NEVER GET AN ALARM AND THE BATTERIES END UP DYING. THIS TRANSMITTER WAS BEING USED AS A REGULAR GZ AND NOT BEING USED IN HI-Q. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 481524 | GZ-130PA | TRANSMITTER | DRT | NIHON KOHDEN CORPORATION | GZ-130PA | NA | 04931921117415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | CNS.| CNS.| CNS. |