MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-920PA

Model Number ZM-920PA

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

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

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned by the customer.The unit has cracked cases and corroded battery contacts.Failure investigation is currently in progress.

Event Description

Customer stated that the batteries inside the transmitter got extremely hot and the unit was taken out of service.

Manufacturer Narrative

Customer stated that the batteries inside the transmitter got extremely hot and the unit was taken out of service.The device was returned by the customer.The unit has cracked cases and corroded battery contacts.The bottom case was replaced and the unit was returned to the customer.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-920PA
• Type of Device: ZM-920PA
• 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 TOMIOKA CORPORATION; 486 nanokaichi; attn: shama mooman; gunma 370-2 343; JA 370-2343
• 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: 5009445
• MDR Text Key: 23220344
• Report Number: 8030229-2015-00214
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup
• Report Date: 08/17/2015,07/20/2015

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-920PA
• Device Catalogue Number: ZM-920PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2015
• Distributor Facility Aware Date: 07/20/2015
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2011
• 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