MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 620 A1; ANESTHESIA GAS MACHINE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 05 december 2019.The fda recall number is z-0813-2020 & z-0814-2020.Customers were sent a letter explaining the issue and were provided the following safety instructions: you can continue to use the anesthesia system.If you observe the message: ventilate manually.Change from mechanical to manual ventilation.At any time, the clinician may use a self-inflating bag to ventilate the patient and/or switch to another anesthesia device.Contact your ge healthcare representative for repair of the device.Perform the planned maintenance (pm) every 12-months at a minimum per the user.Reference manual which includes inspection of the cable connection.Note: this inspection step is included in the annual pm described in the technical reference manual.Performing this step in the pm would confirm the integrity of the cable connection.

Event Description

As a result of an inspection that was completed as part of ge healthcare field modification, this unit was identified as having a loose cable connection that would cause a loss of mechanical ventilation and a high priority audio and visual alarm.

• Brand Name: CARESTATION 620 A1
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: david woodworth ; 3030 ohmeda drive; madison, WI
• MDR Report Key: 9990362
• MDR Text Key: 223801389
• Report Number: 2112667-2020-01327
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/23/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 04/23/2020
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: SEEH10
• Patient Sequence Number: 1