ZM-520PA
Report
- Report Number
- 8030229-2020-00278
- Event Type
- Malfunction
- Date Received
- May 20, 2020
- Date of Event
- April 27, 2020
- Report Date
- November 16, 2021
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- DRT
- UDI-DI
- 04931921115077
- PMA / PMN Number
- K043517
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BATTERIES WERE HOT IN THE TELEMETRY TRANSMITTER. THEY REPLACED THE BATTERIES, BUT THE ISSUE PERSISTED. THEY REQUESTED THAT THE UNIT BE REPAIRED. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED / PERFORMED: EVALUATION / REPAIR: ON 05/05/2020, THE UNIT WAS CLEANED AND DECONTAMINATED BY NIHON KOHDEN AMERICA REPAIR CENTER (NKA RC). ON RC EVALUATION, THE REPORTED PROBLEM COULD NOT BE DUPLICATED. PHYSICAL DAMAGE TO THE FRONT CASE (HAIRLINE CRACK) WAS NOTICED, THE BATTERY CONTACT ON THE REAR CASE WAS CORRODED WITH RESIDUE FOUND ON THE CENTER CASE. ON 05/06/2020, THE FOLLOWING MALFUNCTIONING PARTS WERE RECOGNIZED AND REPLACED WHICH RESOLVED THE ISSUE: # 6142901448B FRONT CASE # CD-323P CENTER CASE #6142902693 REAR WITH BATTERY COVER # 6114918572A CASE SEALANT # 110168 O-RING # 6123906559 MAIN PANEL. THE UNIT WAS TESTED PER THE OPERATOR'S/SERVICE MANUAL AND THE RESULTS WERE RECORDED ON THE MAINTENANCE CHECK SHEET. THE UNIT COMPLETED 24 HOURS OF EXTENDED TESTING AND OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. THE REPAIRED UNIT WAS SHIPPED BACK TO THE CUSTOMER ON 09/23/2020. NO ISSUES HAVE BEEN REPORTED SINCE. INVESTIGATION SUMMARY: THE NKC INVESTIGATION PERFORMED UNDER (B)(4) (A3-181170_FINAL-EG) CONCLUDED THAT INCORRECT INSERTION OF THE BATTERY MAY CAUSE THE BATTERY TERMINAL SPRING TO BREAK THE COATING OF THE BATTERY, LEADING TO A SHORT CIRCUIT. THE OVERALL RISK OF THIS EVENT IS MEDIUM. THE REPORTED ISSUE DOES NOT REQUIRE FURTHER INVESTIGATION THROUGH CAPA PROCESS SINCE THE ISSUE COULD NOT BE DUPLICATED ON NKA RC EVALUATION. HHA CONSIDERED THE PROBABILITY OF HARM AS "UNLIKELY OR REMOTE" IN SUCH REPORTED CASES. ALSO, A NEW DESIGN CHANGE WAS INTRODUCED TO THE TRANSMITTER'S REAR CASE WHICH WOULD ADD AN INSULATING SHEET TO PREVENT SHORT CIRCUIT OF THE BATTERY CAUSED BY INCORRECT BATTERY INSERTION. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE TRANSMITTER: CENTRAL NURSE'S STATION (CNS): MODEL #: CNS-6201A, SERIAL #: (B)(6) .
THE BIOMEDICAL ENGINEER REPORTED THAT THE BATTERIES WERE HOT IN THE TELEMETRY TRANSMITTER. THEY REPLACED THE BATTERIES, BUT THE ISSUE PERSISTED. THEY REQUESTED THAT THE UNIT BE REPAIRED. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER REPORTED THAT THE BATTERIES WERE HOT IN THE TELEMETRY TRANSMITTER. THEY REPLACED THE BATTERIES AND THE ISSUE PERSISTS AND WOULD LIKE THE UNIT REPAIRED. NO PATIENT HARM 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE TELEMETRY TRANSMITTER. CENTRAL NURSE'S STATION: MODEL: CNS-6201A, SN: (B)(4).
THE BIOMEDICAL ENGINEER REPORTED THAT THE BATTERIES WERE HOT IN THE TELEMETRY TRANSMITTER. THEY REPLACED THE BATTERIES AND THE ISSUE PERSISTS AND WOULD LIKE THE UNIT REPAIRED. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540606 | ZM-520PA | TRANSMITTER | DRT | NIHON KOHDEN CORPORATION | ZM-520PA | NA | 04931921115077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | CNS-6201A SN (B)(6) | CNS-6201A SN (B)(6) |