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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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ARJO (SUZHOU) CO., LTD. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number 630009AU
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/25/2022
Event Type  malfunction  
Event Description
Arjo became aware of an auto logic pump malfunction.The burning marks were observed on the mechanically damaged insulation of the power cord.There was no allegation that any patient was involved when the issue was detected.No injury was reported.
 
Manufacturer Narrative
The investigation is ongoing.Results of the analysis will be provided to the follow-up report.
 
Manufacturer Narrative
Arjo became aware of an auto logic pump malfunction.The burning marks were observed on the mechanically damaged insulation of the power cord.There was no allegation that any patient was involved when the issue was detected.No injury was reported.The inspection of the involved system (pump and mattress) conducted by an arjo representative revealed that the power cord was damaged by the bed frame side rail as it was pinched between the side rail and the bed¿s platform.The cable was positioned without use of the cable management flaps because the flaps were ripped from the mattress from unknown reason.The claimed system was part of rental fleet.The mattress and the pump passed all tests before rent (incl.Verification of the cable management channel and electrical safety test) and were delivered fully functional to the customer.At this customer facility, the installation of the auto logic systems is usually done by the customer staff however in this case, it is unknown who installed the claimed pump and if positioned the cable with use cable management flaps to secure the power cable that time.The investigation revealed that lack of use the cable management flaps contributed to the power cord damaged between the bed¿s parts.At time of visit at the customer facility (following the event), the customer staff was aware about the correct power cord installation.According to the instruction for use (b)(6), arjo recommends to ¿make sure that the mains power cable are clear of moving bed mechanisms or other possible entrapment areas.The mains power cable of this pump is designed to allow movement of the bed, and should be fitted into the cable management flaps along the sides of the mattress, as described in this manual.¿ the power cord was found to be damaged and from that perspective, the device did not meet performance specification.It is unknown if there was any patient involved when the pump malfunction occurred.No injury or other medical consequences were reported.The complaint was assessed as reportable due to burning marks on the damaged power cord.
 
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Brand Name
AUTO LOGIC
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
ARJO (SUZHOU) CO., LTD.
no. 158 fangzhou road, sip
suzhou, jiangsu 21502 4
CH  215024
Manufacturer (Section G)
ARJO (SUZHOU) CO., LTD.
no. 158 fangzhou road, sip
suzhou, jiangsu 21502 4
CH   215024
Manufacturer Contact
justyna kielbowska
ks. wawrzyniaka 2
komorniki 62-05-2
PL   62-052
883337089
MDR Report Key15247695
MDR Text Key305522327
Report Number3005619970-2022-00016
Device Sequence Number1
Product Code FNM
UDI-Device Identifier05055982784252
UDI-Public(01)05055982784252(11)190530
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number630009AU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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