MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME ZOOM STRETCHER, BSMART; STRETCHER, WHEELED POWERED

Catalog Number 1125000000BSP

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

Model and serial number of the product not yet known.

Event Description

It was reported via repair work order that the brakes were not holding.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The customer had alleged that the brakes were not holding.The user facility was contacted and it was reported that the brakes were working and that they would contact stryker if any issues presented themselves.The device was not evaluated and no repairs were performed.

Event Description

It was reported that the brakes were not holding.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: PRIME ZOOM STRETCHER, BSMART
• Type of Device: STRETCHER, WHEELED 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6142988
• MDR Text Key: 61603456
• Report Number: 0001831750-2016-00388
• Device Sequence Number: 1
• Product Code: INK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1125000000BSP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2016
• 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