MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-540PA; TRANSMITTER

Model Number ZM-540PA

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Alarm Not Visible (1022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the transmitter did not v-fib alarm while the patient was being monitored on the cns.The device was in use on a patient, however no patient harm was reported.The customer sent the device in and was provided with a transmitter exchange.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

Event Description

The biomedical engineer reported that the transmitter did not v-fib alarm while the patient was being monitored on the cns.

Manufacturer Narrative

The biomedical engineer reported that the transmitter did not v-fib alarm while the patient was being monitored on the cns.The device was in use on a patient; however no patient harm was reported.The customer sent the device in for evaluation and was provided with an exchanged device.The unit was cleaned and evaluated and the reported problem was not duplicated.The unit completed 24 hours of extended testing and operates to manufacturer's specifications.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-540PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; 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 ; 2687488
• MDR Report Key: 6348143
• MDR Text Key: 67931055
• Report Number: 8030229-2017-00049
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921106600
• UDI-Public: 04931921106600
• 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
• Report Date: 02/21/2017,01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-540PA
• Device Catalogue Number: ZM-540PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2017
• Distributor Facility Aware Date: 01/27/2017
• Device Age: 76 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2017
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2010
• 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