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

Model Number MODEL 100

Device Problems Break (1069); No Display/Image (1183); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2015

Event Type  malfunction  

Event Description

It was reported that during use on a cardiac arrest patient, the autopulse platform displayed a user advisory (ua) 12 (lifeband not present) message.Customer also reported that the display screen was loose and the head restraint was damaged from being cut.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 04/01/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection was performed and the reported issues of the head restraint wires being damaged and the lcd being loose were both confirmed.In addition, it was observed that the power button and battery lock pin were damaged.From the condition of the platform, the damages appear to have been caused by normal wear and tear.Functional testing was completed and the platform performed as intended with no user advisories, system errors or warnings exhibited.The reported user advisory (ua) 12 (lifeband not present) could not be duplicated during functional testing.During device inspection, there were no anomalies or mechanical issues that could have caused or contributed to the reported ua 12 code.A review of the platform's archive data was performed and found no user advisories, system errors or warnings on the reported event date of (b)(6) 2015.However, multiple ua 12 codes were seen on (b)(6) 2015 and (b)(6) 2015.As no mechanical issues were identified with the platform that may have led to the ua 12 codes, the most probable cause has been determined to be that the lifeband clip was not detected in the platform's spool shaft due to improper or incomplete installation of the lifeband.Based on the investigation, the parts identified for replacement were the top cover (including head restraint wires), the power button and the battery lock pin.The loose lcd was re-adjusted to its intended position.In summary, the reported complaint of the platform displaying a ua 12 code was confirmed during platform archive review and attributed to improper or incomplete installation of the lifeband.Visual inspection was performed and the reported issues of the head restraint wires being damaged and lcd being loose were both confirmed and attributed to normal wear and tear.Following service, including replacement of the damaged parts and re-adjustment of the lcd, the device passed all testing criteria.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4695929
• MDR Text Key: 5639877
• Report Number: 3010617000-2015-00232
• 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,Followup
• Report Date: 03/25/2015

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: 04/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 04/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2007
• 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