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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 PX3-3005; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO S3 PX3-3005; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number 3005
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.  the devices were evaluated in the field and the issue was confirmed.  however, there were no product malfunctions; the issues were the result of use error as the scales were not properly zeroed before use.There was no remedial action taken.  these devices are not labeled for single use.
 
Event or Problem Description
This report summarizes 2 malfunction events, where it was reported the scale was inaccurate.  there was no patient involvement.
 
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Brand Name
S3 PX3-3005
Common Device Name
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10742814
Report Number0001831750-2020-01117
Device Sequence Number17006864
Product Code FNL
UDI-Device Identifier07613327278354
UDI-Public07613327278354
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized2
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number3005
Device Catalogue Number3005S3PX3
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/01/2020
Initial Report FDA Received Date10/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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