MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

Device Problems Overheating of Device (1437); Failure to Power Up (1476); Failure to Transmit Record (1521); Device Inoperable (1663); Low Battery (2584)

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

Event Date 10/23/2015

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

Nihon kohden received written notification from (b)(6) on 11/13/2015 of a reported incident that occurred on (b)(6) 2015 and was reported to the fda on 10/28/2015, see mw5057585.The customer reported cns (central monitoring system) indicated a low battery, transmitter was checked and it would not power on, batteries were checked and one was hot to the touch.Batteries were replaced, ecg waveform was verified.The patient indicated the device was warm and that the device was warm prior to the batteries being replaced.

Manufacturer Narrative

Manufacturer narrative: nihon kohden received written notification from (b)(6) (ph.D.) at (b)(6) on 11/13/2015 of a reported incident that occurred on (b)(6) 2015 and was reported to the fda on 10/28/2015, see mw5057585.The customer reported cns (central monitoring system) indicated a low battery, transmitter was checked and it would not power on, batteries were checked and one was hot to the touch.Batteries were replaced, ecg waveform was verified.The patient indicated the device was warm and that the device was warm prior to the batteries being replaced.The device was cleaned and evaluated and all malfunctioning parts were replaced.The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 36 hours of extended testing and operates to manufacturer's specifications.The customer was sent an exchange unit.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-531PA
• 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: 5293115
• MDR Text Key: 34015562
• Report Number: 8030229-2015-00443
• Device Sequence Number: 1
• Product Code: DRG
• 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: other,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/13/2015,11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• 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: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2015
• Distributor Facility Aware Date: 11/13/2015
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2015
• Date Manufacturer Received: 12/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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