Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO AIR EXPRESS APM; BED, FLOTATION THERAPY, POWERED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER MEDICAL-KALAMAZOO AIR EXPRESS APM; BED, FLOTATION THERAPY, POWERED Back to Search Results
Catalog Number C1000DF
Device Problems Detachment Of Device Component (1104); Inappropriate/Inadequate Shock/Stimulation (1574); Power Problem (3010)
Patient Problem Electric Shock (2554)
Event Date 06/10/2016
Event Type  malfunction  
Event Description
It was reported that the power inlet had become detached from the unit with exposed bare wires.Allegedly a caregiver received an electrical shock from the exposed wires.However, no medical intervention was reported for the shock.No patient was affected.
 
Manufacturer Narrative
The issue was resolved for the customer by discussing the issue with the account and confirming that nothing further was required at this time.
 
Event Description
It was reported that the power inlet had become detached from the unit with exposed bare wires.Allegedly a caregiver received an electrical shock from the exposed wires.However, no medical intervention was required and no patient was affected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AIR EXPRESS APM
Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6043771
MDR Text Key58299079
Report Number0001831750-2016-00328
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberC1000DF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-