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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3500000730
Device Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2016
Event Type  malfunction  
Event Description
It was reported that the recliner would not lock into place.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
The issue was resolved for the customer by replacing the mechanism (pn: (b)(4).
 
Event Description
It was reported that the recliner would not lock into place due to a bent mechanism assembly.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
PATIENT ROOM WALL SAVER RECL
Type of Device
CHAIR, EXAMINATION AND TREATMENT
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 Key5952762
MDR Text Key55148770
Report Number0001831750-2016-00290
Device Sequence Number1
Product Code FRK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3500000730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2013
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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