MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESCAPE R860; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

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 17 october 2018.The fda recall number is z-0463-2019.The issue of the inspiratory safety guard (isg)is being addressed through the ge healthcare (gehc) reported field modification for this issue per 21 cfr 806 on 17 october 2018.The fda recall number is z-0463-2019.Customers were sent a letter explaining the issue which included photos of the issue and the following safety instructions were provided: safety instructions #1: you may continue to use your ventilator with the isg outlet if the 15mm female conical connector is inspected for a secure fit in the location indicated below where engagement resistance would normally occur (see figure 1 "correct inspiratory safety guard (isg)").Note: an isg currently in use with adult or pediatric patients utilizing 22mm male circuit connection are not associated with this issue and are safe for continued use after inspection of both inlet and outlet issues have been completed.When systems are no longer in use, inspect for 15mm incorrect connection per the instruction in figure 1.

Event Description

The hospital reported a defective ventilator inspiratory safety guard (isg) resulting in a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.

• Brand Name: CARESCAPE R860
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 9583021
• MDR Text Key: 220291127
• Report Number: 2112667-2020-00119
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K142679
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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
• Date Manufacturer Received: 09/26/2019
• Date Device Manufactured: 03/12/2015
• 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