MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number ZM-531PA

Device Problem Temperature Problem (3022)

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

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the transmitter's battery overheated.There was no physical damage or fluid intrusion reported.The device was not in use on a patient at the time.They sent the device in and it is currently awaiting evaluation.The biomedical engineer was provided with an exchanged device.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 that the transmitter's battery overheated.

Manufacturer Narrative

Corrected data: device evaluated by manufacturer, additional manufacturer narrative.Additional information: suspect products, type of report: follow up, type of report (mfr): follow up, device mfr report: additional information/correction, event problem and evaluation codes.Manufacturer narrative: the biomedical engineer reported that the trasnmitter's battery overheated.There was no physical damage or fluid intrusion reported.The device was not in use on a patient at the time.They sent the device in and it has completed the evaluation.The biomedical engineer was provided with an exchange device.The device was cleaned and evaluated.The complaint has been closed due to this complaint being a transmitter overheating steming from an incorrrect battery installation.

• Brand Name: ZM-521PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 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
• MDR Report Key: 6831665
• MDR Text Key: 84078657
• Report Number: 8030229-2017-00279
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• 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: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 08/30/2017
• Distributor Facility Aware Date: 08/03/2017
• Device Age: 24 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2017
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• 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