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

Model Number MODEL 100

Device Problems Break (1069); Device Displays Incorrect Message (2591)

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

Event Date 10/01/2014

Event Type  malfunction  

Event Description

It was reported that at the start of a code, the autopulse platform displayed a "battery message" (exact message was not provided).The crew replaced the battery with a spare, which ran for approximately 14 compressions before the autopulse lifeband "broke".No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 11/18/2014 for investigation.Investigation results as follows: visual inspection of the platform was performed and the battery lock was found to be damaged.The platform was functionally tested and the reported issue of the platform displaying a battery related message was not duplicated.The platform ran with a test battery and mannequin for 10 minutes and an additional 45 minutes with a lrtf (large resuscitation test fixture).No problems were encountered.The platform performed as intended during functional testing.A review of the platform's archive showed no user advisories occurring on the reported event date of (b)(6) 2014.However, the archive does show both user advisory (ua) 2 (compression tracking error) and ua 44 (battery voltage too low during compression) occurring on (b)(6) 2014.Based on the archive data, the reported issue of the platform displaying a battery message was confirmed.The ua 2 observed is also consistent with the reported information stating the lifeband became detached after 14 compressions were performed.The archive data shows the platform displaying the ua 44 as expected, due to use of a low voltage nimh battery (s/n (b)(4)).Following the ua 44, the archive shows that this battery was then replaced by the customer with a second nimh battery (s/n (b)(4)), with no further ua 44 or other battery-related codes being displayed.A review of the archive indicated that the battery being used (nimh battery, s/n (b)(4)) was not fully charged at the time of use, thus leading to the ua 44.Consistent with the reported information, the ua 2 is seen occurring after replacing battery (s/n (b)(4)) with the second battery (s/n (b)(4)).Ua 2 codes typically occur if the patient is misaligned on the platform, the lifeband is opened in some manner during use, or if the load cell connections are faulty.There was no information reported indicating the patient had been misaligned or moved during treatment.There was also no issues identified with the platform's load cells during the evaluation.Based on the evaluation results as well as reported information, the ua 2 code occurred as a result of the lifeband becoming opened or detached in some manner during compressions.Since the lifeband was not returned for a physical evaluation, the reported issue of the lifeband breaking could not be confirmed nor could a cause be determined.Based on the investigation, the part identified for replacement was the damaged battery lock.In summary, the reported issue of the platform displaying a battery message was confirmed through platform archive data showing a ua 44 had expectedly occurred due to use of a low voltage battery.The ua 2 found during archive review is also consistent with the customer reported information indicating that the lifeband became detached following compressions.Since the lifeband was not returned for a physical evaluation, the reported issue of the lifeband breaking could not be confirmed nor could a cause be determined.Please see the following related mfr.Report #3010617000-2014-00625 for autopulse® lifeband with lot #: unknown.

• 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: 4277615
• MDR Text Key: 5034845
• Report Number: 3010617000-2014-00624
• 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: 11/03/2014

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: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2008
• 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