MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, HAND-CARRIED

Catalog Number UNK_MED

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer declined to have repairs made at this time.Customer called and cancelled evaluation.

Event Description

It was reported that the track won't engage due to being broken off.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: STRETCHER, HAND-CARRIED
• 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 Key: 6988616
• MDR Text Key: 90747691
• Report Number: 0001831750-2017-00475
• Device Sequence Number: 1
• Product Code: FPP
• 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
• Report Date: 10/30/2017

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
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/30/2017
• 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