MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. CIC; DETECTOR AND ALARM, ARRHYTHMIA

Device Problems Device Alarm System (1012); Communication or Transmission Problem (2896)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Event Description

It was reported that cic central station did not alarm when the patient desaturated.As a result, the patient required a longer hospitalization.

Manufacturer Narrative

A1-6, e1-3: the information was not provided due to country privacy laws.Investigation findings: it was alleged that on 20 sept 2021 at around 13:30, data from the bedside monitor was not displayed at the cic central station thus, no alarm was provided for a low spo2.The customer acknowledged that the bedside monitor alarmed appropriately.The patient stayed in the hospital longer but did not sustain an injury related to the reported issue.Cic log files were reviewed by ge healthcare engineering which showed that when the bed in question established network connection with the cic on 20 sept 2021 at 13:40, continuous spo2 lo (warning) alarms were asserted.The volume was configured to 80%.The spo2 lo alarms continued until it was silenced by a user at 14:38.The logs also showed a large quantity of out-of-sequence network packets resulting in intermittent loss of monitoring at the cic for that bed.This is indicative of an issue with the network.The gehc field service engineer also identified a faulty wall socket for the monitor's network connection.Moreover, he noted that the no comm alarm had not been enabled at the cic which resulted in no audible alerts; the visual alarms were still present.The customer maintains the network and has not requested any assistance from gehc.Based on the available information, gehc determined the cic did not malfunction.The root cause is a combination of a faulty wall socket with a possible defective network component.Gehc provided their findings and recommended that the customer perform a network assessment.

• Brand Name: CIC
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: kristof soos ; 8200 w tower ave; milwaukee, WI 53221
• MDR Report Key: 12662004
• MDR Text Key: 277344479
• Report Number: 3008729547-2021-00006
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization