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

Model Number MODEL 100

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

Product in complaint was returned to zoll (b)(4) for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Event Description

It was reported that the autopulse platform displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) message.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(6) on 11/16/2015.Investigation results as follows: a visual inspection of the returned autopulse platform was performed and found that the short black cover was damaged.Note this physical damage can occur due to normal wear and tear and/or physical abuse.A review of the archive was performed and user advisory (b)(4) (max motor on time exceeded during active operation) was observed.The platform was functional tested and the autopulse performed both 30:2 and continuous compressions.Load cell characterization was also performed and one of the load cell failed indicating incorrect readings at high loads.The load cell was replaced to remedy the reported complaint of (b)(4).Based on the investigation, one of the load cells was replaced to remedy the reported complaint.In addition, the short black cover was also replaced.In summary, the customer's reported complaint of autopulse displaying (b)(4) was confirmed during archive review and functional testing and was attributed to a defective load cell.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5204314
• MDR Text Key: 30493673
• Report Number: 3010617000-2015-00611
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

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: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2014
• 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