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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA MOVITA; MEDICAL GAS AND VACUUM SYSTEMS
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DRÄGERWERK AG & CO. KGAA MOVITA; MEDICAL GAS AND VACUUM SYSTEMS Back to Search Results
Catalog Number G16707
Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 09/29/2022
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 the device had become detached from the ceiling and was only hanging from the wiring and internal hoses.The device was not in use on the patient.According to the customer, there was personal injury to a cleaning worker involved in the incident.Upon inquiry, no evidence suggesting serious injury to the cleaner was provided.
 
Event Description
It was reported that the device had become detached from the ceiling and was only hanging from the wiring and internal hoses.The device was not in use on the patient.According to the customer, there was personal injury to a cleaning worker involved in the incident.Upon inquiry, no evidence suggesting serious injury to the cleaner was provided.
 
Manufacturer Narrative
The system was examined at the customer site by dräger service.The information gathered during this process, as well as photos, were made available for further investigation.It was not possible to determine the cause of the reported loosening of the screw connections, as the system had already been repaired and put back into operation by the customer at the time of the investigation.The screws cannot loosen on their own as a result of intended use, as it can be proven that they were properly assembled and fastened with the appropriate torque (production test report).This connection was tested and approved in accordance with iso 11197 and iec 60601-1 with up to four times the rated load and crash tests.Based on the photos, it could be determined that an additional cable had been installed compared to the initial delivery condition (to equip a dummy receptacle; a dummy receptacle is a placement location left free (with a dummy cover) that can be retrofitted later).Such a modification is only permitted in consultation with the respective legal manufacturer(s) of the devices, as also stated in the instructions for use.Dräger has no information regarding this modification.Based on this, it is reasonable to assume that an installation error in the course of the customer's modification of the system led to the reported error pattern.Loosening of screw connections is not a sudden process.As stated in the instructions for use, positioning of the system above the patient is not permitted.All dves at the customer site were checked and no other discrepancies were found.Dräger is not contracted to maintain the systems at the customer's site.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
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Brand Name
MOVITA
Type of Device
MEDICAL GAS AND VACUUM SYSTEMS
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 Key15672355
MDR Text Key302699954
Report Number9611500-2022-00290
Device Sequence Number1
Product Code FQO
Combination Product (y/n)N
PMA/PMN Number
D167937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberG16707
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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