MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ZM-930PA; TRANSMITTER

Model Number ZM-930PA

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

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 customer reported that the batteries got hot.

Manufacturer Narrative

Additional manufacturer narrative: the defective device related to this complaint was returned and evaluated.Residue was found on the on/off switch and inside socket of the top case assembly.Battery contact plus was corroded.Device also had low rf output.Burned in for 3 days, retested the device, batteries did not get hot.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-930PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer Contact: thomas bento ; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687708
• MDR Report Key: 5073526
• MDR Text Key: 25616225
• Report Number: 8030229-2015-00253
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup,Followup
• Report Date: 09/13/2015,08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-930PA
• Device Catalogue Number: ZM-930PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2015
• Distributor Facility Aware Date: 08/14/2015
• Device Age: 58 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2016; 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2010
• 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