MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ERGOSTAR CM55; BREATHING HOSE, DISPOSABLE

Catalog Number MP01855

Device Problems Crack (1135); Degraded (1153); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2022

Event Type  malfunction  

Event Description

It was reported that an ergostar (catheter mount) was broken intraoperatively at the connection point to the ventilation tube, without the impact of a third party.This reportedly made ventilation difficult or almost impossible.Ergostar was very hard to remove.No injury reported.

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Manufacturer Narrative

It was initially reported that ventilation was difficult or hardly possible due to the breakage of the ergostar.The pictures of the ergostar provided for this case showed that there were hairline cracks in the material of the connector on the patient's side.No deep cracks or spalling were visible, so that no restriction of ventilation was to be expected.Based on this information, the case subsequently was assessed as not reportable.Through previous complaints, it has become known that disinfectants and certain oils (e.G.Mcp oil) can damage the plastic and produce the present crack pattern.It has been reported by the user that oil or some other agent has been used to create an easier connection between the tube and the ergostar.Therefore, it can be assumed that the use of a lubricant was the cause of the cracking.Since the hospital in question no longer uses lubricants to connect the tube and the ergostar, the symptoms have no longer occurred.A possible leakage caused by the damage is detected before use in the leakage test.If a (relevant) leakage occurs during operation, it will also be detected and alarmed by the connected basic unit.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that an ergostar (catheter mount) was broken intraoperatively at the connection point to the ventilation tube, without the impact of a third party.This reportedly made ventilation difficult or almost impossible.Ergostar was very hard to remove.No injury reported.

• Brand Name: ERGOSTAR CM55
• Type of Device: BREATHING HOSE, DISPOSABLE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 14616823
• MDR Text Key: 297361768
• Report Number: 9611500-2022-00138
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MP01855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NA.; NA.