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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of system error, out of service, revert to manual cpr error message was confirmed based on the archive review and during functional testing.The fault was found to be due to the defective motor drive train.Visual inspection was performed and found the screw post is damaged.One screw post is completely broken and in bits and the screw post cannot be repaired.The physical damage found during visual inspection is considered unrelated to the reported event.The autopulse platform is a reusable device and was manufactured on 09-jan-2017.A review of the archive was performed and the reported complaint of the system error, out of service, revert to manual cpr was confirmed.The archive data shows ua139 (latched system error) occurred on the reported event date due to the autopulse is unable to maintain compression position/depth is likely caused by an internal component malfunctioned.Functional testing was performed and the reported issue of system error, out of service, revert to manual cpr error message was confirmed.The autopulse stops several times on the normal manikin with ua17.The autopulse did not reach target depths within specification and it was due to the defective motor drive train.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform serial number (b)(4).

Event Description

During patient use, the autopulse platform ((b)(4)) performed continuous compression for an unspecified amount of time and then displayed "system error, out of service, revert to manual cpr" message.No known impact or consequence to the patient was reported.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7513042
• MDR Text Key: 108232682
• Report Number: 3010617000-2018-00544
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001274
• UDI-Public: 00849111001274
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• 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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2017
• 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