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

Model Number ZM-541PA

Device Problems Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001); Intermittent Communication Failure (4038)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2020

Event Type  malfunction  

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 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.

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 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
• 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 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
• MDR Text Key: 195420426
• Report Number: 8030229-2020-00069
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• 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: 02/10/2020,01/16/2023

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
• Device Operator: 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
• Date Report Sent to FDA: 02/10/2020
• Distributor Facility Aware Date: 01/23/2020
• Device Age: 72 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• 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: CNS
• Patient Outcome(s): Hospitalization
• Patient Sex: Male