MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

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

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

The reported autopulse platform stopped compressions was not confirmed.Unrelated to the reported complaint, visual inspection revealed a crack front enclosure, a bent battery lock and two missing grip strips.The autopulse underwent functional testing with a large mannequin fixture (equivalent to 250 pounds patient) for 15 minutes.The platform passed functional testing with no fault.The archive review identified several faults for ua17 (max motor on time exceeded during active operation).The brake gap was adjusted to reduce the chance of a re-occurrence for this fault.The platform under went preventative maintenance and service repair to specifications.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial (b)(4).

Event Description

During patient care, the device stopped compressions after five repetitions and the crew went to manual compressions.The user was able to clear the code but the fault reappeared repeatedly.No patient care was compromised as user reverted to manual cpr immediately.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood avenue; san jose, CA 95131
• MDR Report Key: 7445967
• MDR Text Key: 106306464
• Report Number: 3010617000-2018-00453
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2013
• 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