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

Model Number MODEL 100

Device Problems Break (1069); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

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

Event Date 02/23/2015

Event Type  malfunction  

Event Description

It was initially reported that during patient use, customer observed that the metal cable near the top of the autopulse platform where the strap attaches was broken.Customer also reported that the allen screws on the back of the platform where the lifeband attaches became loose.The reported issues did not effect patient care.No adverse patient sequelae was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During review of the platform's archive data, it was observed that user advisory (ua) 2 (compression tracking error) and ua 17 (max motor on time exceeded during active operation) messages occurred on the reported event date of (b)(6) 2015.Although the customer did not report this, a user advisory message is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 03/02/2015 for investigation.Investigation results as follows: visual inspection was performed and found that the top cover and bottom enclosure were damaged, thus confirming the initial reported complaint.From the condition of the platform, the damages appear to have been due to wear and tear.The platform ran with a test manikin and no issues were observed.The platform performed as intended during functional testing.Unrelated to the initial reported complaint, multiple user advisory (ua) 2 (compression tracking error) and ua 17 (max motor on time exceeded during active operation) codes were observed on the reported event date.The ua 2 codes likely occurred as a result of patient misalignment on the platform while compressions were being performed.A definitive cause for the ua 17 codes could not be determined.However, it should be noted that there were no mechanical issues found during inspection of the platform, which may have caused or contributed to the ua 17 codes.Based on the investigation, the part(s) identified for replacement were the top cover and the bottom enclosure.In summary, the initial reported complaint was confirmed during visual inspection and attributed to wear and tear.Following service, including replacement of the top cover and bottom enclosure, the device passed all 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: 4659517
• MDR Text Key: 5684038
• Report Number: 3010617000-2015-00224
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/23/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2008
• 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