MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A; RECEIVER UNIT

Model Number ORG-9700A

Device Problems Application Program Version or Upgrade Problem (2881); Application Security Problem (2882); Device Operational Issue (2914)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org arrhythmia alarm parameters were accessible without the use of a password at the bedside monitor (bsm).This is due to a software compatibility issue with the connected, sun-setted (out of production) bsm device.This parameter setting should not be accessible to the clinical staff, who can alter parameter alarm levels without management over-site.They would like to send the device in for a software upgrade to resolve the issue.No patient harm was reported.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 org arrhythmia alarm parameters were accessible without the use of a password at the bedside monitor (bsm).

Manufacturer Narrative

Additional manufacturer narrative: the customer reported that the org arrhythmia alarm parameters were accessible without the use of a password at the bedside monitor (bsm).This is due to a software compatibility issue with the connected, sun-setting (out of production) bsm device.This parameter setting should not be accessible to the clinical staff, who can altar parameter alarm levels without management oversite.The customer sent the unit in for a software upgrade to resolve the issue.The unit was cleaned, evaluated and the software was updated.The unit completed 24 hours of extended testing and operates to manufacturer's specifications.

Manufacturer Narrative

H10: additional narrative: on 3/1/2018 nk clinical application specialist (b)(6) reported asystole settings were not greyed out on this device, mu-970ra s/n: (b)(6) with org receiver 9700 software 01-11.This setting should be greyed out to prevent settings from being accessible to user without password protection.A health hazard analysis (hha) was performed to assess the risks.Capa: 18-09 was opened to determined if actions were necessary.Under hha, software upgrade was recommended.This upgrade was performed under service notification#: (b(4).Service requested: software upgrade.Service performed: software upgrade.Investigation result: the root cause of the reported issue was due to software incompatibility for sunsetted products.Software upgrade to compatible software version resolved the issue.Customer's service history shows that this is an isolated event.Corrected information: g4.Date received by manufacturer: should be 03/01/2018 not 03/08/2018 as listed on mdr initial report.H3.Device evaluated by manufacturer?: device evaluation anticipated, but not yet begun incorrectly selected.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.Correction.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The customer reported that the org arrhythmia alarm parameters were accessible without the use of a password at the bedside monitor (bsm).

• Brand Name: ORG-9700A
• Type of Device: RECEIVER UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7325317
• MDR Text Key: 101978314
• Report Number: 8030229-2018-00063
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9700A
• Device Catalogue Number: MU-970RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2019
• Distributor Facility Aware Date: 07/18/2019
• Device Age: 157 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2019
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1