MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number	ZM-541PA
Medical Device Problem Codes	Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001); Intermittent Communication Failure (4038)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that one of their patients fell while a transmitter was attached to them.The customer also reported that they could not confirm that this happened because of the transmitter.The customer will be sending in their adverse event form to supplement the reported event.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.The following fields contain no information (ni), as attempts to obtain information were made but not provided: age at time of the event, patient sex, patient weight, ethnicity, race, relevant tests/laboratory data, including dates, other relevant history, including preexisting conditions.
Event or Problem Description
The customer reported that one of their patients fell while a transmitter was attached to them.The customer also reported that they could not confirm that this happened because of the transmitter.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the transmitter was giving intermittent signal loss at the central nurse's station (cns).The customer additionally reported that one of their patients fell while the transmitter was attached to them, however no patient injury was reported as a result of the fall.The customer also reported they could not confirm that this happened because of the transmitter.The customer sent in their adverse event form to supplement the reported event.Service performed: exchange.Investigation summary: the root cause for signal loss was found to be related to user workflow issues.The customer was leaving the batteries in the zm transmitters even when not in use which caused corrosion on the battery contacts, resulting in signal loss.User workflow was corrected, and the issue of signal loss was resolved.The root cause of this issue is user error and is not the result of a device malfunction of an nk device.
Event or Problem Description
The customer reported that one of their patients fell while a transmitter was attached to them.The customer also reported that they could not confirm that this happened because of the transmitter.

• Brand Name: ZM-541PA
• Common Device Name: 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 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: 9690760
• Report Number: 8030229-2020-00069
• Device Sequence Number: 2756010
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023
• Report Date (Section F): 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ZM-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2020
• Device Age: 72 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 02/10/2020