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 Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported the patient had removed her telemetry pack to change clothes in the restroom, at which time she experienced a cardiac arrest and expired.The monitoring technicians noticed there were no visible vitals on this patient at the central station and notified nurses who then checked on her, confirming she had expired.The director of nursing confirmed this was not an issue with our device and that the transmitter was, in fact, not connected to the patient.Therefore, this event is not considered to be likely to have caused or contributed to the patient's death.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The biomedical engineer reported the patient had removed her telemetry pack to change clothes in the restroom, at which time she experienced a cardiac arrest and expired.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, japan 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: 6649029
• MDR Text Key: 77829882
• Report Number: 8030229-2017-00204
• 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
• Report Date: 06/16/2017

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
• 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: 06/16/2017
• Distributor Facility Aware Date: 06/09/2017
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2017
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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