MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number ZM-521PA

Device Problems Electrical /Electronic Property Problem (1198); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the patient claimed that the transmitter delivered her a shock.The customer indicated that no injury or death occurred as a result of the shock or medical intervention required.The customer also indicated that the device was inspected and returned to nihon kohden; however, we have not received the device at this time.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.

Event Description

The customer reported that the patient claimed that the transmitter delivered her a shock.No patient harm reported.

Manufacturer Narrative

Details of the complaint: nka was made aware that a patient at (b)(6) hospital claimed the transmitter (zm-521pa (b)(6)) delivered her a shock.The following information is provided by (b)(6), the bme manager at (b)(6) hospital via adverse event information form.There was no injury or death.The date of the event was (b)(6) 2019, and the bme was informed 7 days after the incident.The device was inspected, and the issue could not be reproduced.The bme has no previous service history on the device that may be related to the incident.Investigation result: per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.The transmitter was delivered to (b)(6) hospital on (b)(6) 2018.Review of device sap history found no other complaint reported for this unit.The bme at the facility tested the unit and was unable to reproduce the issue.The bme had no previous service history on the device that may be related to the symptom or incident.The zm-520 and zm-530 series telemetry transmitter is an internally powered equipment which operates on two aa (lr6) type alkaline dry cell primary batteries.The rated voltage is 3.0 v, and the operating voltage is 1.4 - 3.2 v.Per nka clinical assessment performed for a similarly reported issue (300113578), the risk of potential harm is low due to the unit being a low voltage device.Additionally, ecg and impedance method respiration for the transmitter was designed for protection against electrical shock with the use of defibrillation-proof type cf applied part, and spo2 was designed with the use of defibrillation-proof type bf applied part.This is in line with safety standard iec 60601-1.The severity of the issue of [transmitter delivering shock] is determined to be minor (possible first aid treatment necessary, no hospitalization required).Using qe team report, analysis of complaints created against the zm-520 and zm-530 series transmitters for issues of "shock" revealed the following: ticket notification number created on model serial description: 21645 300113578 (b)(6) 2018 zm-520pa 2135 patient claimed he/she got shocked.22429 300115103 (b)(6) 2018 zm-521pa 2781 patient shocked by leads.75064 300193395 (b)(6) 2020 zm-521pa 2900 transmitter may have shocked a patient.In all 3 cases, no patient injury had resulted due to the reported shock.The devices were tested at the respective hospitals and the issue could not be reproduced.The total number of zm-520 and zm-530 devices in distribution is approximately (b)(4) for the zm-520 series and (b)(4) for the zm-530 series (information taken from hha 19-009 for an unrelated issue).(b)(4).The probability that the issue of [transmitter delivering shock] will occur is determined to be rare (less than 1% of the time).Investigation conclusion: the unit (sn (b)(6) ) was not returned to nka for evaluation.The issue was reported to nka over 2 months after the incident occurred, making attempts at gathering time sensitive information difficult.From the information available, and as the reported issue could not be duplicated upon customer's evaluation of the device, the root cause could not be determined.Per sop07-014, the overall risk of the issue of [transmitter delivering shock] is determined to be low.The following fields are not applicable (na) to the mdr report: d4 lot number & expiration date.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The customer reported that the patient claimed that the transmitter delivered her a shock.No patient harm reported.

• Brand Name: ZM-521PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 9604436
• MDR Text Key: 200822032
• Report Number: 8030229-2020-00037
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2020
• Distributor Facility Aware Date: 01/29/2020
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2020
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1