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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

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NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9110A
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2022
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org displayed communication loss (comm loss) at the central nurse's station (cns).The customer located the org in the closet and rebooted.Once the unit was rebooted, the comm loss went away.There was no patient injury reported.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.Additional model information: concomitant medical device: the following device was used in conjunction with the org: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.
 
Event Description
The customer reported that the org displayed communication loss (comm loss) at the central nurse's station (cns).There was no patient injury reported.
 
Manufacturer Narrative
Details of complaint: the customer reported that the org displayed communication loss (comm loss) at the central nurse's station (cns).The customer located the org in the closet and rebooted.Once the unit was rebooted, the comm loss went away.There was no patient injury reported.Investigaton summary: as the device was not returned for evaluation, root cause cannot be determined.As the issue was resolved after the org was rebooted, it is unlikely that the issue is related to a deficiency in hardware.As the root cause is unlikely to be related to a device malfunction, the issue was resolved by rebooting, and the incident likely being an isolated incident based on complaint history reviews of the customer account and device serial number.The following fields are not applicable (na) to this report: b2 d4 lot # & expiration date d6a & d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: (b)(6)/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the org: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: ni additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h10 additional manufacturer narrative manufacturer references # 300293481 - 140181 follow up 001.
 
Event Description
The customer reported that the org displayed communication loss (comm loss) at the central nurse's station (cns).There was no patient injury reported.
 
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Brand Name
ORG-9110A
Type of Device
MULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
attn: shama mooman
1-1 tajino
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 Key14581515
MDR Text Key294058830
Report Number8030229-2022-02878
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/17/2022
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 NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/06/2022
Initial Date FDA Received06/02/2022
Supplement Dates Manufacturer Received07/25/2022
Supplement Dates FDA Received08/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CNS; CNS
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