MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CHAIR, ADJUSTABLE, MECHANICAL; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 1460000000

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices wer not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.4 devices were evaluated in the field and the issue was confirmed; 3 devices had worn components and 1 device had alignment issues.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 6 malfunction event(s), where it was reported the brakes would not hold.There was no patient involvement.

• Brand Name: CHAIR, ADJUSTABLE, MECHANICAL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 9234684
• MDR Text Key: 163649349
• Report Number: 0001831750-2019-00984
• Device Sequence Number: 1
• Product Code: INN
• UDI-Device Identifier: 07613327282665
• UDI-Public: 07613327282665
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1460000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1