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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE (SUZHOU) CO. LTD. AUTO LOGIC
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GETINGE (SUZHOU) CO. LTD. AUTO LOGIC Back to Search Results
Model Number 630004DE
Device Problems No Audible Alarm (1019); Decrease in Pressure (1490)
Patient Problem Pressure Sores (2326)
Event Date 12/20/2014
Event Type  malfunction  
Event Description
On january 29, 2015, it has been reported to arjohuntleigh that there was a problem with auto logic system.It was stated that the mattress was totally flat, however, the pump did not show any alarm.The pt developed minor pressure ulcers due to defected pump.
 
Event Description
On january 29, 2015, it has been reported to arjohuntleigh that there was a problem with auto logic system.It was stated that the mattress was totally flat, however, the pump did not show any alarm.The pt developed minor pressure ulcers due to defected pump.Ref (b)(4).
 
Manufacturer Narrative
(b)(4).Add'l info will be provided upon conclusion of the investigation.
 
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Brand Name
AUTO LOGIC
Manufacturer (Section D)
GETINGE (SUZHOU) CO. LTD.
no. 158 fangzhou road
sip, suzhou, jiangsu
suzhou
Manufacturer (Section G)
GETINGE (SUZHOU) CO. LTD.
no. 158 fangzhou road
sip, suzhou, jiangsu,
suzhou
Manufacturer Contact
pamela wright
12625 wetmore, ste 308
san antonio, TX 78247
2102787040
MDR Report Key4561814
MDR Text Key48929238
Report Number3005619970-2015-00005
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number630004DE
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2015
Distributor Facility Aware Date01/29/2015
Device Age3 NA
Event Location Hospital
Date Report to Manufacturer02/26/2015
Initial Date Manufacturer Received 01/29/2015
Initial Date FDA Received02/27/2015
Date Device Manufactured12/01/2012
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;
Patient Age63 YR
Patient Weight85
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