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

Model Number ZM-521PA

Device Problems Overheating of Device (1437); Device Inoperable (1663)

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

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter was getting extremely hot while on a patient.The customer put fresh batteries in and put the transmitter on a simulator.The batteries immediately began to swell up.The device was returned to nihon kohden, evaluated, and the reported issue was not able to be confirmed.When the transmitter was received and examined it was noted that there was difficulty in installing the battery due to mechanical issues with the battery's minus contact in the battery housing of the rear case assembly.The customer was provided with a transmitter exchange.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.

Event Description

The customer reported that the transmitter was getting extremely hot while on a patient.

Manufacturer Narrative

Manufacturer narrative: the customer reported that the transmitter was getting extremely hot while on a patient.The customer put fresh batteries in and put the transmitter on a simulator.The batteries immediately began to swell up.The device was returned to nihon kohden, evaluated, and the reported issue was not able to be confirmed.When the transmitter was received and examined it was noted that there was difficulty in installing the battery due to mechanical issues with the battery's minus contact in the battery housing of the rear case assembly.The customer was provided with a transmitter exchange.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-521PA
• 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 CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; gunma 161-8 560; JA 161-8560
• 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: 5415015
• MDR Text Key: 37617418
• Report Number: 8030229-2016-00045
• Device Sequence Number: 1
• Product Code: DRT
• 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: 02/05/2016,01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2016
• Distributor Facility Aware Date: 01/06/2016
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2016
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• 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