MAUDE Adverse Event Report: MICHIGAN INSTRUMENTS, LLC THUMPER; EXTERNAL CARDIAC COMPRESSOR

Model Number 1007CC

Device Problem Mechanical Problem (1384)

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

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

Upon receipt of the device, an evaluation will be made and a follow-up report will be submitted.

Event Description

Approximately 2 minutes after mechanical compressions began the device began to slow and eventually stopped compressions.Device immediately removed from patient and manual compressions resumed.

Manufacturer Narrative

Device was evaluated by the manufacturer and the reported customer problem could not be confirmed.Two individual test runs of 25 and 30 minute durations, performed on separate days, revealed normal and proper operation of the device in both instances.Device was thoroughly inspected and re-tested to factory specifications.Unit passed all final tests and was returned to the customer.

• Brand Name: THUMPER
• Type of Device: EXTERNAL CARDIAC COMPRESSOR
• Manufacturer (Section D): MICHIGAN INSTRUMENTS, LLC; 4717 talon ct. se; grand rapids MI 49512
• MDR Report Key: 8613218
• MDR Text Key: 145618493
• Report Number: 1821850-2019-00001
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K972525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1007CC
• Device Catalogue Number: 15350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 161