MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number ZM-520PA

Device Problems Device Alarm System (1012); Protective Measures Problem (3015)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their transmitter missed an arrhythmia alarm.No patient harm or 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.

Event Description

The customer reported that their transmitter missed an arrhythmia alarm.No patient harm or injury was reported.

Event Description

The customer reported that their transmitter missed an arrhythmia alarm.No patient harm or injury was reported.

Manufacturer Narrative

Details of complaint: on (b)(6) 2020, the customer reported that the transmitter missed an arrhythmia alarm.No patient harm or injury was reported.Nihon kohden (nk) technical support (ts) contacted the customer and found that the reported problem has been resolved.However, the customer provided no information as to how.Service requested / performed: troubleshooting.Investigation summary: no root cause could be established as the customer provided no additional information regarding this event.The overall risk of this event is "low." the reported issue does not require further investigation through capa process.The following fields are not applicable (na) to the mdr report: d4 lot # & expiration date g4 device bla number the following fields contain no information (ni), as attempts to obtain information were made, but not provided: additional device information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: cns: model #: ni serial #: ni additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• Brand Name: ZM-520PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 10171763
• MDR Text Key: 195728290
• Report Number: 8030229-2020-00324
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• 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: 06/18/2020,07/21/2021

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-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2020
• Distributor Facility Aware Date: 05/27/2020
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS