MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY VISTA XL; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number MS18986

Device Problems Crack (1135); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Fell (4014)

Patient Problems Low Oxygen Saturation (2477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/15/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that two patient monitoring systems that were mounted to the wall with a dedicated holder fell down to the floor.There was no detail in the report which would reasonably suggest that a patient, user or third person may have been hurt.

Event Description

It was reported that two patient monitoring systems that were mounted to the wall with a dedicated holder fell down to the floor.There was no detail in the report which would reasonably suggest that a patient, user or third person may have been hurt.

Manufacturer Narrative

The follow-up 1 accidentally contained information regarding a different case with the mdr number 1220063-2023-00031.Therefore, the information in the previous follow-up 1 can be disregarded.Involved parts have been returned to the manufacturer for evaluation, photos from the wall mounting system have been provided as well.The reported aspect can be confirmed in general - a plastic part of the mounting system was broken which caused that the monitor could detach from the wall mounting system and fell down to the floor which resulted in severe damage.The design of the mounting system can be explained as follows: the monitors of the infinity series have a dedicated docking station that allows the so-called pick-and-go operation.The docking station has all the cable connections embedded and will be fixed/mounted to the area of use which can be e.G.A patient bed, an anesthesia workstation or a wall mounting system.The monitor itself will be arrested to the docking station by means of a guide rail system that facilitates an uplock mechanism.Investigation of the parts and photos revealed that the docking station was cracked into pieces; one part with the ground plate that fixes it to the wall holder was still attached to the latter but the other part of the docking station with the guide rails system and the lock was still arrested to the monitor.The housing of the docking station is made of specific plastic material that is reinforced to withstand high mechanical forces and, post market surveillance data reasonably suggests that the design and the wall thickness of the parts is appropriate for the typical use conditions.No other similar complaint is known.The area of cracking looks homogeneous insofar that no signs of earlier cracking can be observed.No indication for a material or manufacturing defect could be found - the entire part broke as a consequence of one single event of mechanical overload, other explanations can be excluded.The other monitors at this facility that are mounted to the wall were all checked and, no further issues were found which also substantiates the conclusion of accidental misuse as the root cause for the event.The exact conditions that led to the overload and breaking cannot be reconstructed.

Manufacturer Narrative

The user stated that the deviation between set and delivered fio2 values was related to the knob of the dosage valve which was moving freely on its axxis.Dräger has initiated repeated requests to obtain further information but those were not responded to.Hence, it is not possible to differentiate between the most likely scenarios of either knob becoming loose over time or due to a sudden event in form of impact of too high mechanical force.The entire device has a useful product life of 7 years - the unit involved in the particular incident was in use for more than 8 years already when the event occurred.The oxygen blender is subject to re-calibration in intervals of two years, a beginning loosening of the knob will most likely be detected.It is not known due to missing feedback when the last calibration cycle was performed.

Event Description

It was reported that draeger resuscitative may not have been delivering adequate oxygen.There was a temporary desaturation reported but no further symptoms or consequences.

• Brand Name: INFINITY VISTA XL
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck MA ; GM
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 17649557
• MDR Text Key: 322256924
• Report Number: 1220063-2023-00029
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K070566
• 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,Followup
• Report Date: 02/02/2024
• 2 Devices were Involved in the Event: 1 2

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
• Device Catalogue Number: MS18986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 11/16/2023; 08/14/2023
• Supplement Dates FDA Received: 01/19/2024; 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2012
• 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