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

Model Number ZM-531PA

Device Problem Failure to Analyze Signal (1539)

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

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) states that a patient had three pauses but only two alarmed.The first pause was 4 seconds long and alarmed as bradycardia, the second was 5 seconds long and alarmed asystole, the third pause was 6 seconds long and it did not alarm on the transmitter device.When reviewing in full disclosure, the customer states that in all three episodes there was a lead off but the first two still caused an alarm.Settings are all appropriate.Reviewed good electrode skin prep, placement and changing ever 24 hours.

Event Description

The biomedical engineer (bme) states that a patient had three pauses but only two alarmed.

• 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: 6972937
• MDR Text Key: 90102865
• Report Number: 8030229-2017-00357
• 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
• Report Date: 10/24/2017

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-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2017
• Distributor Facility Aware Date: 09/07/2016
• Device Age: 63 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2017
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2012
• 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