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

Model Number ZM-521PA

Device Problem Power Problem (3010)

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

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their transmitter intermittently shuts off and on.The customer also reported that when they connect this device to new batteries, it takes a while for it to start up.No harm or injury was reported.They will be sending this transmitter in for an exchange.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 intermittently shuts off and on.

Event Description

The customer reported that their transmitter intermittently shuts off and on.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter would intermittently shut off and then power back on randomly.They also reported that when replacing the batteries with new ones, it would take a while for it to start up.No harm or injury was reported.Investigation summary: startup failures attributed to the zm 5xxx transmitters may be caused by physical damage, battery failure or power board failure.A review of the history of the serial number identified no other reports of the issue.Based on the available information a definitive root cause could not be identified.

• Brand Name: ZM-521PA
• 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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10219656
• MDR Text Key: 198360076
• Report Number: 8030229-2020-00351
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/01/2020,02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2020
• Distributor Facility Aware Date: 06/11/2020
• Device Age: 92 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2020
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1