MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

Device Problems Power Problem (3010); Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter (tele) is going to a black screen and shutting off.They have tried to use different batteries, but the unit still blanks out and shuts off.Not in patient use.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 biomedical engineer (bme) reported that the telemetry transmitter (tele) is going to a black screen and shutting off.They have tried to use different batteries, but the unit still blanks out and shuts off.Not in patient use.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter (tele) is going to a black screen and shutting off.They have tried to use different batteries, but the unit still blanks out and shuts off.Not in patient use.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the telemetry transmitter (tele) is going to a black screen and shutting off.They have tried to use different batteries, but the unit still blanks out and shuts off.Not in patient use.Investigation conclusion: the customer replied in a follow-up on (b)(6) 2024 to cancel their exchange request.A definitive root cause could not be determined since we have not received the device.Possible causes may include user error with battery usage or hardware component failure.User error may include incorrect battery insertion or use of batteries with low charge.Hardware component failure can occur due to physical damage or fluid intrusion from user mishandling, electrical damage from incorrect battery use, or wear-and-tear which depends on device age and frequency of use.Review of the complaint device's serial number shows that the unit is 10 years old and has 1 other complaint under ticket 300343205 where the customer requested an exchange due to one of the buttons falling off, but root cause could not be determined since we did not receive the device and the customer was unresponsive to follow-up attempts.Due to the age of the device, wear-and-tear may be a likely contributing factor to possible hardware component failure.The following fields are not applicable (na) to the mdr report: a2 - a6 b2 b6 - b7 d4 lot number & expiration d6a - d6b d7b d10 concomitant medical device f1 - f14 g4 device bla number g5 g7 h7 h9 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.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter (tele) is going to a black screen and shutting off.They have tried to use different batteries, but the unit still blanks out and shuts off.Not in patient use.

Manufacturer Narrative

Corrected information: d4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a, per the fda request.Additional information: b4 data of this report.G6 type of report.H2 if follow up, what type?.

• Brand Name: ZM-531PA
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18005095
• MDR Text Key: 326515226
• Report Number: 8030229-2023-03820
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: (01)04931921115107(21)2013
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2024

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-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 01/17/2024; 01/17/2024
• Supplement Dates FDA Received: 01/17/2024; 07/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2013
• 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
• Treatment: NI.; NI.; NI.