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U.S. Department of Health and Human Services

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

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NIHON KOHDEN CORPORATION ZM-920PA Back to Search Results
Model Number ZM-920PA
Device Problem High Readings (2459)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2019
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the transmitter. The device was in use on a patient at the time, however no patient harm was reported. The customer will receive an exchange device. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The customer reported that the transmitter was reading an incorrect heartrate. Transmitter was showing a value of 150+ even though the patient's hr was only 90. Nihon kohden is attempting to contact the customer to process an exchange. No patient harm was reported.
 
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Brand NameZM-920PA
Type of DeviceZM-920PA
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
486 nanokaichi
attn: shama mooman
tomioka city, 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
MDR Report Key8449814
MDR Text Key139807830
Report Number8030229-2019-00066
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 Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberZM-920PA
Device Catalogue NumberZM-920PA
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/21/2019
Distributor Facility Aware Date08/20/2019
Device Age176 MO
Event Location Hospital
Date Report to Manufacturer08/21/2019
Date Manufacturer Received08/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNOT APPLICABLE

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