MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that when they went into the room the patient was dead.They do not know if an alarm sounded or not.Nihon kohden technical support informed the customer that we need the log files from the unit in order to conduct an investigation.It is not known at this time whether or not there was a malfunction with the transmitter that was connected to the patient.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 reported that when they went into the room the patient was dead.

Manufacturer Narrative

Additional manufacturer narrative: the initial submission was erroneously submitted as a 5 day report.The initial submission should have been marked as a 30 day report.The incident reported in the initial report does not require nihon kohden to initiate action to prevent an unreasonable risk of substantial harm.Nihon kohden continues to investigate the initially reported event and will submit a supplement 002 report in accordance with 803.56 when additional information becomes available.

Manufacturer Narrative

The transmitter came in with ecg cables.The hinge to the battery door was broken.However, the transmitter could be tested with a known working test org for arrhythmias and with a working spo2 test cable for appropriate detection.Per the event list, the transmitter performed as expected - alarming for arrhythmias as well as spo2 limit.The rest of the system was not returned for evaluation.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, 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: 6991208
• MDR Text Key: 90700499
• Report Number: 8030229-2017-00386
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• 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: 10/31/2017

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-530PA
• Device Catalogue Number: ZM-530PA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 10/31/2017
• Distributor Facility Aware Date: 10/30/2017
• Device Age: 24 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2017
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: 10/31/2017; 10/31/2017
• Supplement Dates FDA Received: 10/31/2017; 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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
• Patient Outcome(s): Death