MAUDE Adverse Event Report: RONDISH COMPANY LIMITED DEROYAL; NURSE CALL CORD, UNIVERSAL

Model Number M2300-NC

Device Problem Communication or Transmission Problem (2896)

Patient Problem Not Applicable (3189)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the deroyal investigation team received the device for evaluation.This device is purchased from an outside vendor and distributed by (b)(4).Deroyal is in the process of sending the device onto manufacturer for testing.We will provide follow up report if additional information becomes available.There was no actual adverse event reported.The malfunction occurred during the testing phase before the alarms were used on a patient.Root cause: deroyal has not received results from the devices evaluation.We are currently unable to determine a root cause.Corrections: a replacement was provided to customer.Corrective action: deroyal has not received results from the devices evaluation.We are unable to determine if corrective action is necessary.Preventive action: deroyal has not received results from the devices evaluation.We are unable to determine if preventive action is necessary.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

The quality issue details and the outcome details section copied below are responses given by the initial reporter to the deroyal complaint questionnaire.Quality issue details: date of occurrence: (b)(6) 2016.When did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? health professional.Was a medical procedure involved? no.Name of medical procedure: not applicable.Did the quality issue cause a delay in the medical procedure? not applicable.Detailed description of quality issue: cord would not allow alarm system to work with hospital call system.Changed to another deroyal cord and system worked.How was the quality issue was identified? by actual use.How was the product being used? plug into hospital call system and deroyal alarm.Was it the initial use of the product? yes.Was the product modified from the original condition supplied by deroyal? yes.Was the product connected to or used in conjunction with other devices or equipment? yes.Please describe connected equipment type, settings, etc.: hospital call system and deroyal alarm.Outcome details: outcome(s) attributed to quality issue: none.Person(s) affected by outcome(s) checked above: none.Known pre-existing condition(s) of person(s) affected: none specified.Was the incident reported to the fda? no.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: n/a.

Manufacturer Narrative

This device is purchased from an outside vendor and distributed by (b)(4).(b)(4) has received a response from the device manufacturer after analysis of complaint device.It is copied below: correction: this is not a problem we have seen before.Root cause analysis: the connection between the jack end and the cable wiring is broken inside.Cannot determine whether it is a manufacture defect or due to customer damage.Corrective action: no corrective action at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: DEROYAL
• Type of Device: NURSE CALL CORD, UNIVERSAL
• Manufacturer (Section D): RONDISH COMPANY LIMITED; unit g & h, 4/f, block 1,; kwai tak ind,15-33 kwai tak st; kwai chung, hong kong ; CH
• Manufacturer (Section G): SMART CAREGIVER; 1229 n. mcdowell blvd.; petaluma CA 94954
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell 37849 ; 8653621013
• MDR Report Key: 5756435
• MDR Text Key: 48404718
• Report Number: 1060680-2016-00014
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2016,08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2300-NC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/02/2016
• Date Report to Manufacturer: 06/02/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other