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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-920PA; TELEMETRY TRANSMITTER
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NIHON KOHDEN CORPORATION ZM-920PA; TELEMETRY TRANSMITTER Back to Search Results
Model Number ZM-920PA
Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2014
Event Type  malfunction  
Event Description
Customer stated that the zm-920pa telemetry transmitter had intermittent signal loss.The device also gets hot while powered on.No on a pt.Mfr ref #8030229-2014-00089.
 
Manufacturer Narrative
Although the device was not on a pt, if the malfunction were to occur there is likelihood that a pt could suffer a skin burn.The intermittent signal loss is easily detected by the central monitoring system (cns) and if the malfunction should recur, it is not likely to cause or contribute to death or injury.Device repaired and returned to customer.
 
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Brand Name
ZM-920PA
Type of Device
TELEMETRY TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
Manufacturer Contact
1-31-4 nishiochia, shinkuku-ku
tokyo 161-8-560
8587050350
MDR Report Key4371095
MDR Text Key5234205
Report Number2080783-2014-00089
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/21/2014
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 NumberZM-920PA
Device Catalogue NumberZM-920PA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/01/2004
Device Age11 YR
Event Location Hospital
Date Report to Manufacturer11/28/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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